code product unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg...
TRANSCRIPT
Code Product Unit
EPY0000055
EPY0000116
EPY0000500
EPY0000354
EPY0000427
EPA0040000
EPY0000359
Acamprosate calcium - Reference Spectrum
Acamprosate impurity A 3-aminopropane-1-sulphonic acid
Acarbose
Acarbose for identification
Acarbose for peak identification
Acebutolol hydrochloride
Acebutolol impurity B N-[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl) amino]propoxy]phenyl]acetamide (diacetolol)
Acebutolol impurity C N-(3-acetyl-4-hydroxyphenyl)butanamide
Acebutolol impurity I N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]phenyl)butanamide
Aceclofenac - Reference Spectrum
Aceclofenac for peak identification
Aceclofenac impurity F benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate
Aceclofenac impurity H [[[[[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetyl]oxy]acetyl]oxy]acetic acid
Acemetacin
Acemetacin impurity A 4-chlorobenzoic acid
Acemetacine impurity mixture
Acesulfame potassium
Acesulfame potassium impurity B 5-chloro-6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide
Acetazolamide
Acetazolamide for system suitability
Acetylcholine chloride
Acetylcysteine
Acetylcysteine impurity C N,N'-diacetyl-L-cystine
Acetylcysteine impurity D N,S-diacetyl-L-cysteine
ß-Acetyldigoxin β-Acetyldigoxin for peak identification
Acetylsalicylic acid
Acetylsulfadiazine
N-Acetyltryptophan
N-Acetyltyrosine
Acholeplasma laidlawii BRP
Aciclovir
Aciclovir for system suitability
Aciclovir for peak identification 1
Aciclovir for peak identification 2
Actaea racemosa HRS
Actaea racemosa for assay CRS
Acitretin
Actaea rasemosa dry extract for system suitability HRS
Adapalene
Adapalene impurity C 1-[2-(methyloxy)phenyl]tricyclo[3.3.1.1]decane
Adapalene for peak identification
Adenine
unit
50 mg
94.7 mg
10 mg
40 mg
50 mg
10 mg
EPY0000127
EPY0000128
EPY0000056
EPY0001094
EPY0000085
EPY0000086
EPY0000810
EPY0000811
EPY0000842
EPA0070000
EPA0070020
EPA0100000
EPY0001084
EPY0000002
EPA0150000
EPA0152000
EPA0153000
EPY0000565
EPY0000642
EPA0200000
New EPY0001462
EPA0208000
EPA0202000
EPY0000693
EPA0220000
EPY0001264
EPY0001271
EPY0001269
New EPY0001463
New EPY0001543
EPA0225000
New EPY0001464
EPY0001121
EPY0001120
EPY0001119
EPA0230000
20 mg
0.004 mg
unit
10 mg
20 mg
10 mg
100 mg
10 mg
0.06 mg
50 mg
50 mg
100 mg
0.0068 mg
50 mg
50 mg
10 mg
10 mg
50 mg
10 mg
15 mg
0.002 mg
125 mg
200 mg
1 mL
75 mg
10 mg
0.3 mg
0.004 mg
1200 mg
300 mg
100 mg
1200 mg
100 mg
6 mg
2.022 mg
50 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 251
Table of content
European Pharmacopoeia
Code Product Unit
EPA0230200
EPY0000110
EPY0000882
EPY0000883
EPA0300000
EPY0000740
EPY0000707
EPY0000728
EPA0325000
EPA0325100
EPA0325200
EPA0325450
EPA0325451
EPA1225000
EPA0325500
EPA0325800
EPY0000832
EPA0349000
EPA0350000
EPA0350010
EPA0350020
EPA0350030
EPA0350040
EPA0350050
EPA0351000
EPY0000235
EPY0000255
EPA0357000
EPA0360000
EPY0000054
EPY0000606
EPY0000843
EPY0000687
EPY0000595
EPY0000607
EPA0363000
EPA0363700
EPA0900000
EPA0365000
EPA0368000
New EPY0001467
EPA0365900
EPY0001117
EPA0370000
EPY0000020
Adenosine
Adipic acid
Adrenaline
Adrenaline with impurity F
Adrenaline tartrate
Adrenaline impurity mixture
Adrenaline tartrate with impurity A
Agnus castus fruit standardised dry extract
Alanine
Albendazole
Alcuronium chloride
Alfacalcidol
Alfacalcidol - Reference Spectrum
Alfadex
Alfentanil hydrochloride - Reference Spectrum
Alfuzosin hydrochloride
Alfuzosin for system suitability
Allantoin
Allopurinol
Allopurinol impurity A 5-amino-1H-pyrazole-4-carboxamide
Allopurinol impurity B 5-formylamino-1H-pyrazole-4-carboxamide
Allopurinol impurity C 5-(4H-1,2,4-triazol-4-yl)1H-pyrazole-4-carboxamide
Allopurinol impurity D ethyl 5-amino-1H-pyrazole-4-carboxylate
Allopurinol impurity E ethyl 5-(formylamino)-1H-pyrazole-4-carboxylate
Allylstrychnine bromide
Almagate
Almagate - Reference Spectrum
Alprazolam Controlled Substance
Alprenolol hydrochloride
Alprostadil
Altizide
Altizide impurity B 3-[(2,2-dimethoxyethyl)sulphanyl]prop-1-ene
Alverine citrate
Alverine for peak identification
Alverine impurity D N-(3-cyclohexylpropyl)-N-ethyl-3-phenylpropan-1-amine
Amantadine hydrochloride
Ambroxol hydrochloride
Amfetamine sulfate - Reference Spectrum
Amidotrizoic acid dihydrate
Amikacin
Amikacin impurity I (2S)-4-amino-2-hydroxybutanoic acid
Amikacin sulfate
Amikacin for system suitability
Amiloride hydrochloride
Amiloride impurity A methyl-3,5-diamino-6-chloropyrazine-2-carboxylate
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
50 mg
50 mg
5 mg
10 mg
100 mg
0.005 mg
15 mg
200 mg
60 mg
50 mg
50 mg
5 mg
unit
150 mg
unit
10 mg
10 mg
60 mg
100 mg
10 mg
10 mg
10 mg
10 mg
20 mg
10 mg
25 mg
unit
100 mg
100 mg
50 mg
150 mg
15 mg
5 mg
0.125 mg
10 mg
100 mg
125 mg
unit
100 mg
200 mg
20 mg
200 mg
10 mg
100 mg
10 mg
252 Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000173
EPA0420000
EPA0460000
EPA0496000
EPA0496005
4-Aminobenzoic acid
Aminocaproic acid
7-Aminodesacetoxycephalosporanic acid
Aminoglutethimide
Aminoglutethimide impurity A (3RS)-3-(3-aminophenyl)-3-ethylpiperidine-2,6-dione; (3-aminoglutethimide)
Aminoglutethimide impurity D 3,3'-[diazenediyldi(4,1-phenylene)]bis(3-ethylpiperidine-2,6-dione) (azoglutethimide)
Amiodarone hydrochloride
Amiodarone impurity D (2-butyl-benzofuran-3-yl)-(4-hydroxy-3,5-diiodophenyl)methanone
Amiodarone impurity E (2-butylbenzofuran-3-yl)(4-hydroxyphenyl)methanone
Amisulpride
Amisulpride impurity B 4-amino-N-[[(2RS )-1-ethylpyrrolidin-2-yl] methyl]-5-(ethyl sulphonyl)-2-hydroxybenzamide
Amitriptyline hydrochloride
Amlodipine besilate
Amlodipine for peak identification
Amlodipine impurity A 3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-2-[[2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2- yl)ethoxy]methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
Amlodipine impurity B 3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-6-methyl-2-[[2-[[2- (methylcarbamoyl)benzoyl]amino]ethoxy]methyl]-1,4-dihydropyridine-3,5-dicarboxylate
Amlodipine impurity G dimethyl 4-(2-chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
Ammonio methacrylate copolymer (type A) - Reference Spectrum
Ammonio methacrylate copolymer (type B) - Reference Spectrum
Amobarbital Controlled Substance
Amobarbital sodium Controlled Substance
Amoxicillin trihydrate
Amphotericin B
Amphotericin B for microbiological assay
Amphotericin B for peak identification
Ampicillin (anhydrous)
Ampicillin trihydrate
Amylmetacresol
Amylmetacresol for peak identification
Angelica dahuria root
Anhydrotetracycline hydrochloride
Antazoline hydrochloride
Apomorphine hydrochloride - Reference Spectrum
Apomorphine hydrochloride hemihydrate
Apomorphine impurity B (Morphine sulfate) (Morphinhemisulfat-Pentahemihydrat) Controlled Substance
Alpha-apo-oxytetracycline
Beta-apo-oxytetracycline
Aprotinin solution BRP
Aprotinin for system suitability
L-Arabinitol
Arbutin
Arginine
Arginine aspartate
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
60 mg
50 mg
20 mg
125 mg
20 mg
EPA0496020
EPA0575000
EPY0000129
EPY0000130
EPA0590000
EPA0590004
EPY0000563
EPY0000049
EPY0001067
EPY0001068
10 mg
100 mg
20 mg
20 mg
10 mg
10 mg
10 mg
150 mg
10 mg
10 mg
EPY0001069 10 mg
EPY0001070
EPY0000302
EPY0000303
EPA0650000
EPA0700000
EPA0800000
EPY0000005
EPY0001361
EPY0001014
EPA1000000
EPA1100000
EPY0001244
EPY0001245
EPY0001386
EPA1200000
EPA1210000
EPY0000172
EPY0001465
New EPY0001471
EPA1220000
EPA1230000
EPA1250000
EPY0001154
EPA1269000
EPY0000806
EPA1270000
EPY0000304
Edition 2012/2013
10 mg
unit
unit
500 mg
500 mg
100 mg
100 mg
100 mg
10 mg
250 mg
150 mg
285 mg
10 mg
160 mg
15 mg
50 mg
unit
15 mg
40 mg
20 mg
20 mg
0.5 mL
2.7 mg
10 mg
100 mg
50 mg
20 mg
253
Table of content
European Pharmacopoeia
Code Product Unit
EPA1271000
New EPY0001323
EPY0001185
EPY0001175
EPY0000079
EPY0000080
EPY0000081
Arginine hydrochloride
Aristolochia
Aristolochic acid I
Aristolochic acid for system suitability
Articaine hydrochloride
Articaine impurity A methyl3-[[2-(propylamino)acetyl]amino]-4-methylthiophene-2-carboxylate
Articaine impurity E methyl 4-methyl-3-[[(2RS)-2-[(1-methylethyl)amino]propanoyl] amino]thiophene-2-carboxylate
Ascorbic acid (Vitamin C)
Ascorbic acid impurity C D-sorbosonic acid
Ascorbic acid impurity D methyl D-xylo-hex-2-ulosonate (methyl D-sorbosonate)
Ascorbyl palmitate
Asparagine monohydrate
Aspartame
Aspartame impurity A 2-(5-benzyl-3,6-dioxopiperazin-2-yl)acetic acid (diketopiperazine)
Aspartic acid
Astragaloside IV
Atenolol
Atenolol for system suitability
Atorvastatine calcium trihydrate
Atorvastatin impurity A desfluoroatorvastatin
Atorvastatin impurity B 3-epi-atorvastatin
Atorvastatin impurity C fluoroatorvastatin
Atorvastatin impurity D 3-[(4-fluorophenyl)carbonyl]-2-(2-methylpropanoyl)-N,3-diphenyloxirane-2-carboxamide
Atorvastatin impurity E ent-atorvastatin
Atracurium besilate
Atracurium for impurity F identification
Atracurium for peak identification
Atropine
Atropine for peak identification
Atropine impurity B (1R,3r,5S)-8-azabicyclo[3.2.1]oct-3-yl (2RS)-3-hydroxy-2-phenylpropanoate (noratropine)
Atropine sulphate
Azaperone
Azathioprine
Azathioprine impurity A 1-methyl-4-nitro-1H-imidazol-5-amine
Azathioprine impurity G 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)sulfanyl]-7H-purin-2-amine (thiamiprine)
Azelastine hydrochloride
Azelastine impurity B 1-benzoyl-2-[(4RS)-1-methylhexahydro-1H-azepin-4-yl]diazane
Azelastine impurity D 4-(4-chlorobenzyl)phthalazin-1(2H)-one
Azelastine impurity E 3-(4-chlorobenzilidene)isobenzofuran-1(3H)-one
50 mg
140 mg
1 mg
1 mg
100 mg
15 mg
10 mg
EPA1300000
EPY0001024
EPY0001170
EPY0000800
EPY0000305
EPA1320000
EPA1321000
EPA1330000
EPY0001171
EPA1340000
EPY0001089
EPY0001327
EPY0001328
EPY0001329
EPY0001330
EPY0001331
EPY0001332
EPY0000424
EPY0000503
EPY0000504
EPY0000878
EPY0000845
EPY0000816
EPA1400000
EPY0000029
EPA1500000
EPY0001240
EPY0001246
EPY0000326
EPY0000327
EPY0000328
EPY0000329
100 mg
20 mg
10 mg
10 mg
60 mg
40 mg
10 mg
50 mg
40 mg
100 mg
5 mg
150 mg
10 mg
10 mg
10 mg
10 mg
10 mg
120 mg
5 mg
5 mg
30 mg
0.25 mg
10 mg
50 mg
50 mg
100 mg
10 mg
5 mg
25 mg
5 mg
5 mg
5 mg
254 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000306
EPY0000637
EPY0000641
EPY0000307
EPY0000285
EPB0070000
EPB0100000
EPB0200000
EPB0200050
EPY0001273
EPB0250000
EPB0300000
EPY0000295
EPB0305000
EPY0000351
EPY0000352
EPY0000469
EPY0001073
EPY0001025
EPY0001038
EPY0001026
Azithromycin
Azithromycin for peak identification
Azithromycin for system suitability
Azithromycin impurity A 6-demethylazithromycin
B19 virus DNA for NAT testing BRP
Bacampicillin hydrochloride
Bacitracin zinc
Baclofen
Baclofen impurity A (RS)-4-amino-3-(4-chlorophenyl)butyric acid lactam
Baicalin
Bambuterol hydrochloride
Barbital Controlled Substance
Basic butylated methacrylate copolymer - Reference Spectrum
Beclometasone dipropionate anhydrous
Beclometasone dipropionate monohydrate
Beclometasone dipropionate for system suitability
Beclometasone dipropionate for peak identification
Beclometasone dipropionate impurities F and N
Benazepril hydrochloride
Benazepril for system suitability
Benazepril impurity A [(3R)-3-[[(1R)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2-oxo-2,3,4,5-tetrahydro-1H-1- benzazepin-1-yl]acetic acid
Bendroflumethiazide
Bendroflumethiazide impurity A 4-amino-6-(trifluoromethyl)benzene-1,3-disulphonamide
Benfluorex hydrochloride
Benfluorex hydrochloride for system suitability
Benperidol
Benserazide hydrochloride
Benserazide impurity A (RS)-2-amino-3-hydroxypropanohydrazide
Benserazide impurity C (2RS)-2-amino-3-hydroxy-2'-[(1EZ)-(2,3,4-trihydroxybenzylidene)]propanohydrazide
Benserazide for peak identification
Benzaldehyde
Benzalkonium chloride for system suitability
Benzarone (2-ethylbenzofuran-3-yl)(4-hydroxyphenyl)methanone
Benzathine benzylpenicillin
Benzbromarone
Benzethonium chloride
Benzocaine
Benzoic acid
Benzophenone
Benzyl alcohol
Benzyl benzoate - Reference Spectrum
S-Benzylmercaptoacetyltriglycin
Benzylpenicillin potassium
Benzylpenicillin sodium
Berberine chloride
200 mg
15 mg
0.05 mg
10 mg
150 mg
120 mg
150 mg
50 mg
50 mg
10 mg
100 mg
500 mg
unit
150 mg
10 mg
10 mg
10 mg
0.052 mg
160 mg
0.016 mg
10 mg
EPB0400000
EPY0000564
EPY0000044
EPY0000043
EPB0470000
EPB0477000
EPB0477010
EPY0001071
EPY0001079
EPY0001064
EPY0001060
EPB0490000
EPB0500000
EPY0000775
EPB0550000
EPB0600000
New EPY0001470
EPY0000647
EPY0000167
EPB0670000
EPB0680000
EPB0700000
EPB0900000
EPY0001149
100 mg
5 mg
50 mg
360 mg
100 mg
50 mg
20 mg
10 mg
10 mg
150 mg
20 mg
10 mg
125 mg
10 mg
100 mg
50 mg
30 mg
40 mg
50 mg
unit
10 mg
50 mg
200 mg
20 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 255
Table of content
European Pharmacopoeia
Code Product Unit
EPB0950000
EPY0000391
EPB0990000
EPB1000000
EPB1030000
EPB1040000
New EPY0001416
New EPY0001418
EPB1045000
EPB1054000
EPB1055000
EPY0001027
EPY0001065
EPY0001360
EPB1103000
EPB1103100
EPY0001354
EPB1115000
New EPY0001444
New EPY0001448
EPY0001078
EPB1110000
New EPY0001421
EPB1110004
EPY0001059
EPB1116000
EPB1120000
EPB1121000
Betadex
Betahistine dihydrochloride
Betahistine mesilate
Betamethasone
Betamethasone acetate
Betamethasone diproprionate
Betamethasone dipropionate for peak identification
Betamethasone dipropionate for system suitability
Betamethasone sodium phosphate
Betamethasone-17-valerate
Betamethasone-21-valerate
Betamethasone valerate for system suitability
Betamethasone valerate impurity mixture
Betaxolol for peak identification
Betaxolol hydrochloride
Betaxolol impurity A (2RS)-1-(4-ethylphenoxy)-3-[(1-methylethyl)-amino]propan-2-ol
Betaxolol impurity C 2-[[4-[2-(cyclopropylmethoxy)ethyl]phenoxy]methyl]oxirane
Bezafibrate
Bicalutamide
Bicalutamide for system suitability
Bicisate labelling kit
Bifonazole
Bifonazole for system suitability Bifonazole impurity B 4-[(RS)-(biphenyl-4-yl)phenylmethyl]-1H-imidazole trifluoroacetate
Bilberry dry extract
Biotin (Vitamin H)
Biperiden hydrochloride
Biperiden impurity A (1RS)-1-[(1SR,2SR,4SR)-bicyclo[2.2.1]hept-5-en-2-yl]-1-phenyl-3-(piperidin-1-yl)propan-1-ol (endo form)
Bisacodyl
Bisacodyl for peak identification
Bisacodyl for system suitability
Bisoprolol fumarate
Bisoprolol for peak identification Bisoprolol for system suitability method A CRS has been renamed as Bisoprolol for peak identification CRS
Bisoprolol for system suitability Bisoprolol for system suitability method B CRS has been renamed as Bisoprolol for system suitability CRS
Bleomycin sulfate
Boldine
Bordetella pertussis mouse antiserum BRP
Bromazepam Controlled Substance
Bromazepam for system suitability Controlled Substance
Bromhexine hydrochloride
Bromhexine impurity C N-(2-aminobenzyl)-N-methylcyclohexanamine
Bromocriptine mesilate
Bromocriptine mesilate for system suitability
Bromperidol
200 mg
50 mg
100 mg
75 mg
100 mg
150 mg
10 mg
10 mg
100 mg
100 mg
15 mg
25 mg
0.018 mg
15 mg
60 mg
10 mg
5 mg
100 mg
100 mg
15 mg
24 mg
100 mg
10 mg
10 mg
250 mg
20 mg
60 mg
20 mg
EPB1140000
EPY0000608
EPY0000694
EPY0000812
EPY0000877
50 mg
10 mg
5 mg
50 mg
1 mg
EPY0000813 1 mg
EPB1141000
EPY0000434
EPB1142000
EPB1143000
EPY0000645
EPB1145000
EPY0000200
EPB1150000
EPY0000677
EPB1152000
7 mg
30 mg
0.5 mg
60 mg
10 mg
100 mg
10 mg
30 mg
5 mg
100 mg
256 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPB1152050
EPB1153000
EPY0000468
EPY0000470
Bromperidol decanoate
Brompheniramine maleate
Brotizolam Controlled Substance
Brotizolam impurity B 2-bromo-4-(2-chlorophenyl)-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine (demethylbrotizolam)
Brucella melitensis Rev. 1 strain BRP
Budesonide
Budesonide for system suitability
Bufexamac
Buflomedil hydrochloride
Buflomedil impurity B 4-(pyrrolidin-1-yl)-1-(4-hydroxy-2,6-dimethoxyphenyl)butan-1-one
Bumetanide
Bumetanide impurity A 3-nitro-4-phenoxy-5-sulphamoylbenzoic acid
Bumetanide impurity B 3-amino-4-phenoxy-5-sulphamoylbenzoic acid
Bupivacaine hydrochloride
Bupivacaine impurity B (2RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide
Bupivacaine impurity E 6-(butylamino)-N-(2,6-dimethylphenyl)hexanamide
Buprenorphine Controlled Substance
Buprenorphine hydrochloride Controlled Substance
Buprenorphine for system suitability Controlled Substance
Buserelin
D-His-Buserelin
Buspirone hydrochloride
Buspirone for system suitability
Busulfan
Butyl methanesulfonate
Butyl parahydroxybenzoate
Butyl parahydroxybenzoate impurity E 2-methylpropyl 4-hydroxybenzoate (iso-butyl parahydroxybenzoate)
Butylhydroxyanisole
Butylhydroxytoluene Plastic additive 07
Cabergoline
Caffeine
Caffeine for system suitability
Calcifediol
Calcifediol - Reference Spectrum
Calcipotriol (anhydrous) - Reference Spectrum
Calcipotriol monohydrate
Calcipotriol monohydrate - Reference Spectrum
Calcitonin (salmon)
Calcitonin-Gly
N-acetyl-cys1-calcitonin
Calcitriol
Calcitriol - Reference Spectrum
Calcium ascorbate - Reference Spectrum
Calcium folinate
Calcium glucoheptonate
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
60 mg
100 mg
10 mg
10 mg
EPB1155000
EPB1157300
EPY0001148
EPB1156000
EPB1157400
EPB1157410
EPB1158000
EPY0000309
EPY0000310
EPB1160000
EPY0000088
EPY0000089
EPY0001108
EPY0001109
EPY0001122
EPB1168000
EPB1168020
EPY0000131
EPY0000471
EPB1170000
EPY0001304
EPB1217000
EPY0001357
EPB1212000
EPB1215000
EPY0000472
EPC0100000
EPY0000787
EPC0166000
EPC0166001
EPY0000499
EPY0000473
EPY0000474
EPC0200000
EPY0000632
EPC0200010
EPC0225000
EPC0226000
EPC0249000
EPC0250000
EPC0299000
Edition 2012/2013
1 mL
110 mg
10 mg
100 mg
100 mg
20 mg
150 mg
5 mg
5 mg
100 mg
20 mg
20 mg
10 mg
10 mg
10 mg
2 mg
0.5 mg
5 mg
2 mg
50 mg
30 µl
100 mg
15 mg
50 mg
50 mg
100 mg
70 mg
20 mg
5 mg
unit
unit
5 mg
unit
2x0.98 mg
0.4 mL
20 mg
10 mg
unit
unit
100 mg
60 mg
257
Table of content
European Pharmacopoeia
Code Product Unit
EPC0300000
EPC0340000
EPC0350000
EPC0400000
EPC0405000
EPY0001388
New EPY0001387
EPY0001389
EPC0410000
EPC0426000
EPY0000671
EPC0430000
EPY0001182
EPY0001219
EPY0001220
EPY0001221
EPY0000435
New EPY0001450
Calcium gluconate
Calcium levulinate dihydrate
Calcium oxalate monohydrate
Calcium pantothenate
Camphor (racemic)
Candesartan cilexetil
Candesartan cilexetil for peak identification
Candesartan cilexetil for system suitability
Canrenone
Caprylic acid
Capsaicin
Captopril
Captopril for system suitability Captopril impurity B (2S) 1-[(2S)-3-bromo-2-methylpropanoyl]pyrrolidine-2-carboxylic acid
Captopril impurity C (2RS)-2-methyl-3-sulphanylpropanoic acid
Captopril impurity D (2RS)-3-bromo-2-methylpropanoic acid
Captopril impurity E (2S)-1-isobutyryl-pyrrolidine-2-carboxylic acid
Captopril impurity J (2S)-1-[(2S)-3-(acetylsulfanyl)-2-methylpropanoyl]pyrrolidine-2-carboxylic acid (acetylcaptopril)
Carbachol
Carbamazepine
Carbamazepine impurity A 10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide(10,11-dihydrocarbamazepine)
Carbasalate calcium - Reference Spectrum
Carbasalate impurity B 2-[[2-(acetyloxy)benzoyl]oxy]benzoic acid (acetylsalicylsalicylic acid)
Carbenicillin sodium
Carbidopa
Carbimazole
Carbocisteine
Carbon dioxide - Reference Spectrum
Carboplatin - Reference Spectrum
Carboprost trometamol
Carboprost trometamol - Reference Spectrum
Carisoprodol
Carisoprodol impurity A (2RS)-2-(hydroxymethyl)-2-methylpentyl(1-methylethyl)carbamate
Carmellose
Carmustine - Reference Spectrum
Carmustine impurity A 1,3-bis(2-chloroethyl)urea
Carprofen for veterinary use
Carprofen for system suitability
Carteolol hydrochloride - Reference Spectrum
Carteolol for system suitability
Carvedilol - Reference Spectrum
Carvedilol
Carvedilol for system suitability
Carvedilol impurity C (2RS)-1-[benzyl[2-(2-methoxyphenoxy)ethyl]amino]-3-(9H-carbazol-4-yloxy) propan-2-ol
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
100 mg
250 mg
500 mg
60 mg
50 mg
60 mg
10 mg
10 mg
50 mg
200 mg
50 mg
10 mg
20 mg
10 mg
10 mg
10 mg
10 mg
10 mg
EPY0000113
EPC0450000
EPY0000033
EPC0451000
EPY0001161
EPC0455000
EPC0460000
EPC0465000
EPC0470000
EPC0499900
EPC0550000
EPY0000475
EPY0000536
EPY0000035
EPY0000036
EPY0001214
EPC0580004
EPC0580010
EPY0000846
EPY0000884
EPY0000192
EPY0000193
EPY0000075
New EPY0001427
New EPY0001426
EPY0000103
50 mg
200 mg
10 mg
unit
5 mg
50 mg
50 mg
100 mg
60 mg
unit
unit
40 mg
unit
50 mg
10 mg
10 mg
unit
20 mg
30 mg
5 mg
unit
30 mg
unit
50 mg
10 mg
10 mg
258 Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPC0600000
EPC0630000
EPC0640000
EPC0650000
EPC0675000
EPC0682000
EPY0000505
EPC0682300
EPY0000240
EPC0682400
EPC0682410
Casein BRP
Cefaclor
Delta-3-Cefaclor
Cefadroxil
Cefalexin monohydrate
Cefalotin sodium
Cefalotin for impurity B identification
Cefamandole nafate
Cefapirin sodium
Cefatrizine propylene glycol
Cefatrizine impurity A 7-amino-(6R,7R)-3-[(2H-1,2,3-triazol-4-yl)sulfanyl]-methyl-8-oxo-5-thia-1- azabicyclo[4.2.O]oct-2-ene-2-carboxylic acid(7-ACA triazole)
Cefazolin
Cefepime dihydrochloride monohydrate
Cefepime dihydrochloride monohydrate for system suitability
Cefepime impurity E (6R,7R)-7-amino-3-[(1-methylpyrrolidinio)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct- 2-ene-2-carboxylate
Cefixime
Cefoperazone dihydrate
Cefoperazone sodium - Reference Spectrum
Cefotaxime acid
Cefotaxime sodium
Cefotaxime for peak identification
Cefoxitin sodium
Cefpodoxime proxetil
Cefpodoxime proxetil for peak identification
Cefpodoxime proxetil for impurity H identification
Cefprozil
Cefprozil impurity A (2R)-2-amino-2-(4-hydroxyphenyl)acetic acid (p-hydroxyphenylglycine)
Cefprozil for peak identification
Cefprozil impurity mixture
Cefradine
Cefradine for peak identification
Cefradine impurity mixture
Ceftazidime
Ceftazidime for peak identification
Ceftriaxone sodium
Ceftriaxone impurity A E-isomer
Cefuroxime axetil
Cefuroxime sodium
Celecoxib
Celecoxib impurity A 4-[5-(3-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide
Celecoxib impurity B 4-[3-(4-methylphenyl)-5-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide
Celiprolol hydrochloirde
Celiprolol impurity I 1-acetyl-1-(4-ethoxyphenyl)-3,3-diethylurea
Celiprolol for peak identification
Cellulose acetate
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
100 g
450 mg
20 mg
250 mg
150 mg
100 mg
10 mg
125 mg
100 mg
150 mg
60 mg
EPC0682800
EPY0000633
EPY0000634
EPY0001336
150 mg
150 mg
15 mg
10 mg
EPC0684000
EPC0684750
EPC0684800
EPY0000420
EPC0685000
EPY0000506
EPC0688000
EPY0001305
EPY0001306
EPY0001318
New EPY0001371
New EPY0001372
New EPY0001367
New EPY0001368
EPC0690000
EPY0000568
EPY0001174
EPC0690500
EPY0001111
EPC0691000
EPC0692000
EPC0694990
EPC0695000
New EPY0001445
New EPY0001446
New EPY0001447
EPY0000311
EPY0000312
EPY0000239
EPY0000784
Edition 2012/2013
200 mg
100 mg
unit
80 mg
30 mg
10 mg
100 mg
70 mg
10 mg
10 mg
120 mg
20 mg
10 mg
10 mg
300 mg
15 mg
0.04 mg
200 mg
10 mg
80 mg
10 mg
60 mg
150 mg
200 mg
10 mg
10 mg
10 mg
0.02 mg
20 mg
40 mg
259
Table of content
European Pharmacopoeia
Code Product Unit
EPC0698005
EPY0001054
EPC0700000
EPC0980650
EPY0001197
EPC0980651
EPC0984100
EPC0990000
EPY0000073
EPY0000074
EPC1000000
EPC1050000
EPY0000104
EPC1100000
EPY0001298
EPY0001299
EPC1200000
EPC1300000
EPC1350000
EPC1400000
EPC1425000
EPC1435000
EPC1450000
EPC1500000
EPY0000476
EPC1510000
EPC1520000
EPC1540000
EPC1530000
EPY0000569
EPC2223030
EPC1650000
EPC1700000
EPC1800000
EPY0000436
EPY0000437
EPC1900000
EPY0000507
Cellulose acetate butyrate - Reference Spectrum
Cellulose acetate phthalate
Cephaeline hydrochloride
Cetirizine dihydrochloride
Cetirizine for peak identification
Cetirizine impurity A (RS)-1-[(4-chlorophenyl)phenylmethyl]piperazine
Cetostearyl isononanoate - Reference Spectrum
Cetyl alcohol
Cetyl palmitate 15
Cetyl palmitate 95
Cetylpyridinium chloride
Chenodeoxycholic acid
Chitosan hydrochloride
Chlorambucil
Chlorambucil for system suitability
Chlorambucil with impurity G
Chloramphenicol
Chloramphenicol dipalmitate
Chloramphenicol disodium disuccinate
Chloramphenicol palmitate isomer
Chloramphenicol sodium succinate
Chlorcyclizine hydrochloride
Chlordiazepoxide Controlled Substance
Chlordiazepoxide hydrochloride Controlled Substance
Chlordiazepoxide impurity A 7-chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-oxide
Chlorhexidine
Chlorhexidine diacetate
Chlorhexidine dihydrochloride
Chlorhexidine for performance test
Chlorogenic acid
1-(4-Chlorophenyl)-1-phenylethanol Clemastine fumarate impurity C
Chloroquine sulphate
Chlorothiazide
Chlorphenamine maleate
Chlorphenamine impurity A 2-(4-chlorophenyl)-4-(dimethylamino)-2-[2-(dimethylamino)ethyl]butanenitrile
Chlorphenamine impurity C (3RS)-3-(4-chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine
Chlorpromazine hydrochloride
Chlorpromazine impurity A 3-(2-chloro-10H-phenothiazin-10-yl)-N,N-dimethylpropan-1- amine S-oxide (chlorpromazine sulphoxide)
Chlorpromazine impurity D 3-(2-chloro-10H-phenothiazin-10-yl)-N-methypropan-1-amine (demethylchlorpromazine)
Chlorpromazine impurity E 2-chloro-10H-phenothiazine
Chlorpromazine impurity F 3-(4-chloro-10H-phenothiazin-10-yl)-N,N-dimethylpropan-1-amine
Chlorpropamide
Chlorpropamide impurity B 1,3-Dipropylurea
unit
10 mg
15 mg
100 mg
1.01 mg
10 mg
unit
250 mg
60 mg
50 mg
20 mg
125 mg
30 mg
100 mg
10 mg
10 mg
500 mg
100 mg
25 mg
100 mg
1500 mg
100 mg
2x50 mg
100 mg
10 mg
50 mg
10 mg
50 mg
50 mg
20 mg
15 mg
200 mg
100 mg
100 mg
0.01 mg
10 mg
200 mg
10 mg
EPY0000479
New EPY0000508
EPY0001449
EPC1905000
EPC1905020
10 mg
10 mg
2 mg
100 mg
50 mg
260 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPC1915000
EPC1950000
EPY0000779
EPC2000000
EPY0001451
EPC2100000
EPC2150000
EPC2155000
EPC2158000
EPY0000280
EPY0000593
EPC2160000
EPY0000040
EPC2162701
EPC2162702
EPC2162700
EPC2163000
EPY0000361
EPC2170000
EPC2174000
EPC2174002
Chlorprothixene hydrochloride
Chlortalidone
Chlortalidone for peak identification
Chlortetracycline hydrochloride
Chlortetracycline for system suitability
Cholecalciferol
Cholecalciferol for system suitability
Cholesterol
Cholic acid
Chondroitin sulfate sodium
Chondroitin sulfate sodium (marine)
Chymotrypsin BRP
Ciclopirox
Ciclopirox impurity A (RS)-2-(3-cyclohexyl-5-methyl-4,5-dihydroisoxazol-5-yl)acetic acid
Ciclopirox impurity B 6-cyclohexyl-4-methyl-2H-pyran-2-one
Ciclopirox olamine
Ciclosporin
Ciclosporin for system suitability
Cilastatin sodium
Cilazapril
Cilazapril impurity A 1,1-dimethylethyl(1S,9S)-9-[[(S)-1-ethoxycarbonyl-3-phenylpropyl]amino]- 10-oxo-octahydro-6H-pyridazino[1,2a][1,2]diazepine-1-caboxylate
Cilazapril impurity D (1S,9S)-9-[[(R)-1-ethoxycarbonyl-3-phenylpropyl]amino]-10-oxo-octahydro-6H- pyridazino[1,2a][1,2]diazepine-1-carboxylic acid
Cimetidine
Cimetidine hydrochloride
Cimetidine for peak identification
Cimetidine for system suitability
Cinchocaine hydrochloride
Cineole
Cinnarizine
Ciprofibrate
Ciprofibrate for system suitability
Ciprofloxacin
Ciprofloxacin hydrochloride
Ciprofloxacin hydrochloride for peak identification
Ciprofloxacin impurity A 7-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-quinoline-3-carboxylic acid (fluoroquinolonic acid)
Cisplatin
Cisplatin impurity A trans-diamminedichloroplatinium (II)
Cisplatin impurity B amminetrichloroplatinate (-)
Citalopram hydrobromide
Citalopram hydrochloride
Citalopram for system suitability
Citric acid (anhydrous)
Citric acid monohydrate
Cladribine
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
50 mg
150 mg
1.017 mg
100 mg
20 mg
500 mg
1 mL
100 mg
60 mg
250 mg
100 mg
100 mg
100 mg
20 mg
20 mg
150 mg
120 mg
5 mg
10 mg
50 mg
25 mg
EPC2174005 10 mg
EPC2175000
EPC2175500
EPY0001130
EPY0001146
EPC2177000
EPY0000176
EPC2180000
EPY0000362
EPY0000363
EPY0000198
EPC2190000
EPY0000199
EPC2190050
50 mg
100 mg
10 mg
0.5085 mg
60 mg
180 mg
100 mg
5 mg
5 mg
20 mg
100 mg
10 mg
10 mg
EPC2210000
EPY0001018
EPY0001019
EPY0001008
EPY0001007
EPY0000855
EPA1202000
EPC2219000
EPY0000639
Edition 2012/2013
100 mg
10 mg
10 mg
5 mg
5 mg
0.06 mg
50 mg
50 mg
50 mg
261
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000609
EPY0000610
EPY0000320
EPY0000321
New EPY0001193
EPY0000269
EPC2221000
EPC2223000
EPC2248000
EPC2248010
EPC2250000
EPC2269000
EPY0000364
EPY0000205
EPY0000241
EPY0000559
EPY0000570
EPY0000571
Cladribine for peak identification
Cladribine impurity C 2-chloro-7H-purin-6-amine
Clarithromycin
Clarithromycin for peak identification
Clazuril
Clazuril for system suitability
Clebopride malate
Clemastine fumarate
Clenbuterol hydrochloride
Clenbuterol impurity B 1-(4-amino-3,5-dichlorophenyl)-2-[(1,1-dimethylethyl)amino]ethanone (clenbuterol ketone)
Clindamycin hydrochloride
Clindamycin phosphate
Clioquinol
Clobazam - Reference Spectrum
Clobazam impurity A 7-chloro-5-phenyl-1,5-dihydro-1,5-dihydro-3H-1,5-benzodiazepine-2,4-dione
Clobetasol propionate
Clobetasol for peak identification
Clobetasol impurity J (17R)-4'-chloro-5'-ethyl-9-fluoro-11ß-hydroxy-16ß-methylspiro[androsta-1,4-diene- 17,2'(3'H)-furan]-3,3'-dione (17 alpha-spiro compound)
Clobetasone butyrate
Clobetasone butyrate for system suitability
Clodronate disodium tetrahydrate
Clodronate impurity D (chloromethylene)bis(phosphonic acid)
Clofazimine
Clofazimine for system suitability
Clofibrate
Clomifene citrate
Clomifene citrate for performance test
Clomipramine hydrochloride
Clomipramine impurity C 3-(3-chloro-5H-dibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-1-amine
Clomipramine impurity D 3-(3,7-dichloro-10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl) N,N-dimethylpropan-1-amine
Clomipramine impurity F 3-chloro-10,11-dihydro-5H-dibenzo[b,f]azepine
Clonazepam Controlled Substance
Clonazepam - Reference Spectrum
Clonazepam impurity B 3-Amino-4-(2-chlorophenyl)-6-nitro-1H-quinolin-2-one
Clonidine hydrochloride
Clonidine impurity B 1-acetyl-2-[(2,6-dichlorophenyl)amino]-4,5-dihydro-1H-imidazole
Clopamide
Clopamide for system suitability
Clopidogrel hydrogen sulfate
Clopidogrel for system suitability
Clopidogrel impurity A (2S)-(2-chlorophenyl)[6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]acetic acid
Closantel sodium dihydrate
10 mg
5 mg
160 mg
40 mg
10 mg
10 mg
100 mg
100 mg
30 mg
10 mg
200 mg
250 mg
5 mg
unit
10 mg
40 mg
2 mg
0.4 mg
EPC2285000
EPY0001137
EPY0000888
EPY0000885
EPY0000313
EPY0000358
EPC2300000
EPC2320000
EPC2332000
EPC2360000
EPY0000132
EPY0000133
50 mg
30 mg
5 mg
5 mg
150 mg
10 mg
0.5 mL
50 mg
50 mg
100 mg
10 mg
10 mg
EPY0000134
EPC2385000
EPY0000286
EPC2385015
EPC2400000
EPY0000801
EPY0000833
EPY0000848
EPY0001333
EPY0001334
EPY0001335
EPY0000392
5 mg
50 mg
unit
5 mg
100 mg
20 mg
40 mg
10 mg
60 mg
100 mg
10 mg
20 mg
262 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000393
EPC2424400
EPC2424550
EPC2424500
EPC2425600
EPC2430000
EPY0000818
EPY0000849
EPC2450000
EPC2460000
EPY0000758
New EPY0001472
EPY0000162
EPC2480000
EPY0000722
EPC2500000
EPY0000334
Closantel for system suitability
Clostridia (multi-component) rabbit antiserum (for vaccines-vet.use) BRP
Clostridium tetani guinea pig antiserum (for vaccines-human use) BRP
Clostridium tetani guinea pig antiserum (for vaccines - vet.use) BRP
Clostridium tetani rabbit antiserum (for vaccines - vet.use) BRP
Clotrimazole
Clotrimazole impurity E (2-chlorophenyl)phenylmethanone (2-chlorobenzophenone)
Clotrimazole for peak identification
Cloxacillin sodium
Clozapine
Clozapine for peak identification
Coagulation Factors V, VIII, XI and XIII plasma
Cocaine hydrochloride - Reference Spectrum
Cocoyl caprylocaprate
Codeine Controlled Substance
Codeine - Reference Spectrum
Codeine impurity A 7,8-didehydro-4,5α-epoxy-3,6α-dimethoxy-17-methylmorphinan (o-methylcodeine) Controlled Substance
Codeine hydrochloride dihydrate - Reference Spectrum
Codergocrine mesilate
Colchicine
Colchicine for system suitability
Colestyramine
Colistimethate sodium
Colistin sulfate
Colistin sulfate for microbiological assay
Copovidone - Reference Spectrum
Cortisone acetate
Coumarin
Cotton wool standard for neps
Crospovidone
Crotamiton
Crotamiton impurity A N-ethyl-N-(2-methylphenyl)but-3-enamide
Cyanidin chloride
Cyanocobalamin
Cyclizine hydrochloride
Cyclizine impurity A 1-methylpiperazine
Cyclizine impurity B diphenylmethanol (benzhydrol)
Cyclobenzaprine hydrochloride
Cyclopentolate hydrochloride
Cyclopentolate for system suitability
Cyclophosphamide
Cyproheptadine hydrochloride
Cyproheptadine impurity C 5-(1-methylpiperidin-4-yl)-5H-dibenzo[a,d][7]annulen-5-ol
20 mg
1 mg
3x1 mg
1 mg
1 mg
100 mg
15 mg
1 mg
200 mg
60 mg
0.41 mg
2x1 mg
unit
40 mg
20 mg
unit
10 mg
EPC2500100
EPC2510000
EPC2580000
EPY0000209
EPY0000374
EPC2600000
EPY0000277
EPC2700000
EPC2725000
EPC2800000
EPY0000438
EPC2900000
EPY0001053
EPC2970000
EPC2970005
EPY0001061
EPC3000000
EPC3090000
EPY0000886
EPY0000887
EPC3200000
EPC3245000
EPY0001088
EPC3250000
EPC3280000
EPY0001095
unit
60 mg
15 mg
10 mg
10 mg
20 mg
25 mg
25 mg
unit
250 mg
80 mg
1000 mg
5 mg
100 mg
70 mg
20 mg
20 mg
50 mg
15 mg
10 mg
100 mg
2x50 mg
60 mg
50 mg
30 mg
5 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 263
Table of content
European Pharmacopoeia
Code Product Unit
EPC3283000
EPY0001390
EPY0001223
EPC3290000
EPC3300000
EPC3350000
EPY0000733
EPY0000734
EPY0000735
EPD0070000
EPY0000600
EPD0100000
EPD0125000
EPD0120000
EPD0160000
EPD0201000
EPY0000611
EPD0300000
EPD0350000
EPY0000228
EPD0406200
EPD0430000
EPD0431000
EPY0001321
EPD0480000
EPY0000879
EPY0000807
EPD0500000
EPD0600000
EPD0630000
EPD0650000
EPY0000509
EPY0000510
EPD0400000
EPY0000001
EPD0660020
EPD0700000
EPY0001177
EPD0710000
EPY0001169
EPY0000538
EPY0000511
EPD0718000
EPD0720000
New EPY0001477
EPD0720800
Cyproterone acetate
Cyproterone acetate for peak identification
Cyproterone impurity mixture
Cysteine hydrochloride monohydrate
Cystine
Cytarabine
Dacarbazine
Dacarbazine impurity A 3,7-dihydro-4H-imidazo[4,5-d]-1,2,3-triazin-4-one (2-azahypoxanthine)
Dacarbazine impurity B 5-amino-1H-imidazole-carboxamide
Dalteparin sodium
Danaparoid sodium
Dapsone
Daunorubicin hydrochloride
Daunorubicinone Daunorubicin aglycone
Deferoxamine mesilate
Dehydrohexetidine 2-ethyl-N-[[1-(2-ethylhexyl)-4-methyl-4,5-dihydro-1H-imidazol-4-yl]methyl]hexan-1-amine
Dembrexine hydrochloride monohydrate
Demeclocycline hydrochloride
N-Demethylerythromycin A
Demethylflumazenil - Reference Spectrum
Deptropine citrate
Dequalinium chloride
Dequalinium chloride for performance test
Dermatan sulfate and oversulfated chondroitin sulfate
Desacetylvinblastine
Desflurance - Reference Spectrum
Desflurane impurity A 1,1'-oxybis(1,2,2,2-tetrafluoroethane)
Desipramine hydrochloride
Deslanoside
Desmethylmetrifonate
Desmopressin
Desogestrel
Desogestrel for system suitability
Desoxycortone acetate
Detomidine hydrochloride
Detomidine impurity B (RS)-(1-benzyl-1H-imidazol-5-yl)(2,3-dimethylphenyl)methanol
Dexamethasone
Dexamethasone for system suitability
Dexamethasone acetate
Dexamethasone acetate impurity E 9-fluoro-11beta,17-dihydroxy-16alpha-methyl-3,20-dioxopregn-4-en-21-yl acetate
Dexamethasone isonicotinate
Dexamethasone isonicotinate for impurity C identification
Dexamethasone pivalate
Dexamethasone sodium phosphate
Dexamethasone sodium phosphate for peak identification
Dexchlorpheniramine maleate
30 mg
5 mg
0.01 mg
50 mg
100 mg
150 mg
20 mg
20 mg
10 mg
250 mg
10 mg
100 mg
100 mg
10 mg
30 mg
50 mg
10 mg
100 mg
10 mg
unit
60 mg
50 mg
50 mg
1 mL
2x1 mg
unit
1 mL
100 mg
150 mg
30 mg
0.98 mg
50 mg
10 mg
100 mg
100 mg
20 mg
50 mg
10 mg
100 mg
0.013 mg
10 mg
10 mg
50 mg
100 mg
10 mg
60 mg
264 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPD0730000
EPD0731000
EPD0731005
EPD0732000
EPD0733000
EPD0734000
EPD0735000
EPD0736000
EPD0737000
EPD0738000
EPD0739000
EPY0000744
EPD0740000
EPY0000261
EPY0001058
EPY0001150
EPD0940000
EPY0000596
EPD0950000
EPD0970000
EPD1000000
EPY0000480
EPY0000481
EPD1010000
EPY0000275
EPY0000259
EPY0000264
EPD1039990
EPS0765000
EPD1040000
EPD1050000
EPD1060000
EPY0000439
EPY0000440
EPY0000441
EPY0000442
Dexpanthenol
Dextran
Dextran 1
Dextran Vo
Dextran 4 for calibration
Dextran 10 for calibration
Dextran 40 for calibration
Dextran 70 for calibration
Dextran 250 for calibration
Dextran 40 for performance test
Dextran 60/70 for performance test
Dextranomer
Dextromethorphan hydrobromide
Dextromethorphan impurity A ent-3-methoxymorphinan
Dextropropoxyphene hydrochloride Controlled Substance
Dextropropoxyphene for system suitability Controlled Substance
Diazepam Controlled Substance
Diazepam for system suitability Controlled Substance
Diazoxide
Dibenzocycloheptene
Dibenzosuberone
Dibrompropamidine diisetionate
Dibrompropamidine for system suitability
Dibutyl phthalate
Dichlorodiaminocyclohexaneplatinum
Diclazuril for system suitability
Diclazuril for veterinary use - Reference Spectrum
Diclofenac potassium
Diclofenac sodium
Diclofenac impurity A 1-(2,6-dichlorophenyl)-indolin-2-one
Dicloxacillin sodium
Dicycloverine hydrochloride
Didanosine
Didanosine for system suitability
Didanosine impurity A 1,7-dihydro-6H-purin-6-one (hypoxanthine)
Didanosine impurity G 9-(2,3-dideoxy-β-D-glycero-pentofuranosyl)-9H-purin-6-amine (2',3'-dideoxyadenosine)
Dienestrol
Diethanolamine fusidate
Diethylcarbamazine citrate
Diethylene glycol (monoethyl ether) - Reference Spectrum
Diethyl phthalate
Diethylstilbestrol
Diethylstilbestrol dimethyl ether
Diethylstilbestrol monomethyl ether
Difloxacin hydrochloride
Difloxacin impurity G 7-chloro-6-fluoro-1-(4-fluorophenyl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
Diflunisal
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
5 mg
25 mg
50 mg
10 mg
50 mg
50 mg
50 mg
50 mg
50 mg
50 mg
50 mg
50 mg
100 mg
5 mg
10 mg
5 mg
30 mg
0.5 mg
50 mg
20 mg
100 mg
10 mg
20 mg
1 mL
10 mg
20 mg
unit
100 mg
100 mg
0.005 mg
250 mg
100 mg
10 mg
10 mg
10 mg
10 mg
EPD1200000
EPD1250000
EPD1300000
EPY0000217
EPD1410000
EPD1500000
EPD1600000
EPD1700000
New EPY0001423
New EPY0001429
EPD1750000
Edition 2012/2013
150 mg
50 mg
250 mg
unit
1 mL
100 mg
10 mg
10 mg
60 mg
15 mg
30 mg
265
Table of content
European Pharmacopoeia
Code Product Unit
EPD1800000
EPY0000640
EPD1900000
EPY0000554
EPD1940001
EPY0000232
EPY0000216
EPY0000053
EPD1945000
EPD1950000
EPY0000831
EPD1952000
EPD1954000
EPY0000544
EPY0000482
EPD1980000
New EPY0001439
Digitoxin
Digoxigenin
Digoxin
Digoxin for peak identification
Dihydralazine sulphate (hydrated) - Reference Spectrum
Dihydralazine for system suitability
Dihydrocodeine hydrogen tartrate - Reference Spectrum
17 alpha-dihydroequilin
Dihydroergocristine mesilate
Dihydroergotamine mesilate
Dihydroergotamine for peak identification
Dihydroergotamine tartrate
Dihydrostreptomycin sulfate (for LC assay)
Dihydrotachysterol
Dihydrotachysterol for system suitability
Diltiazem hydrochloride
Diltiazem impurity F (2S,3S)-5-[2-(dimethylamino)ethyl]-3-hydroxy-2-(4-methoxyphenyl)-2,3-dihydro-1,5- benzothiazepin-4(5H)-one
Diltiazem for system suitability
Dimenhydrinate
N,N-Dimethylacetamide - Reference Spectrum
Dimenhydrinate for peak identification
Dimethyl sulfoxide
Dimeticone
Dimetindene maleate
Dinoprost trometamol
Dinoprostone
Dinoprostone impurity C (E)-7-[(1S,2R,3R)-3-hydroxy-2-[(E)-(3S)-3-hydroxyoct-1-enyl]- 5-oxocyclopentyl]-hept-5-enoic acid (5-trans-PGE2;(5E)-PGE2)
Diosmin
Diosmin for system suitability
Diphenhydramine hydrochloride
Diphenhydramine impurity A 2-(diphenylmethoxy)-N-methylethanamine
Diphenoxylate hydrochloride - Reference Spectrum
Diphenoxylate hydrochloride Controlled Substance
Diphenoxylate for system suitability Controlled Substance
Diphtheria toxin BRP
Diphtheria vaccine (absorbed) BRP
Dipivefrine hydrochloride
Dipivefrine for system suitability
Dipotassium clorazepate - Reference Spectrum
Diprophylline
Dipyridamole
Dipyridamole for peak identification
Dirithromycin
Disodium edetate
Disopyramide
Disopyramide phosphate
Disulfiram
200 mg
5 mg
30 mg
10 mg
unit
10 mg
unit
10 mg
250 mg
100 mg
10 mg
150 mg
25 mg
30 mg
5 mg
300 mg
10 mg
EPY0001141
EPD2000000
EPY0000234
EPY0001103
EPD2050000
EPD2200000
EPD2205000
EPD2255000
EPD2250000
EPD2250015
10 mg
100 mg
unit
1 mg
1 mL
200 mg
50 mg
60 mg
100 mg
10 mg
EPY0000094
EPY0000095
EPD2600000
EPY0000135
EPD2630000
New EPY0001415
New EPY0001430
EPY0000258
EPD2700000
EPY0000376
EPY0000394
EPD2750100
EPD2800000
EPD2850000
EPY0000802
EPD2880000
EPD2900000
EPD2920000
EPD2922000
EPD2950000
70 mg
5 mg
100 mg
10 mg
unit
15 mg
10 mg
1 mL
32 mg
100 mg
10 mg
unit
100 mg
50 mg
2 mg
100 mg
100 mg
100 mg
100 mg
100 mg
266 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPD2953000
EPD2953025
EPD2953050
EPD2954000
EPY0001239
New EPY0001452
Dithranol
Dithranol impurity C Dithranol-dimer 4,4',5,5'-tetrahydroxy-9,9'-bianthracenyl-10,10'(9H,9'H)-dione
Dithranol impurity D 1-hydroxyanthracen-9(10H)-one
Dobutamine hydrochloride
Dobutamine impurity mixture
Docetaxel impurity E 5ß,20-epoxy-4-(acetyloxy)-1,7ß,10ß,13-tetrahydroxy-9-oxotax-11-en-2-yl benzoate (10-desacetyl-baccatin III)
Docetaxel trihydrate
Docetaxel for system suitability
Anhydrous Docetaxel
Docosahexaenoic acid ethyl ester
Docusate sodium - Reference Spectrum
Dodecyl gallate
Domperidone
Domperidone maleate
Dopamine hydrochloride
Dopexamine dihydrochloride
Dopexamine impurity B 2-methoxy-4-[2-[[6-[(2-phenylethyl)hexyl]amino]ethyl]phenol
Dopexamine impurity F 4-Chloro-5-[2-[[6-[(2-phenylethyl)amino]hexyl]amino]ethyl]benzene-1,2-diol
Dorzolamide hydrochloride
Dorzolamide impurity A (4R,6R)-4-(ethylamino)-6-methyl-5,6-dihydro-4H-thieno[2,3-b] thiopyran-2-sulphonamide 7,7-dioxide
Dorzolamide for system suitability
Dosulepin hydrochloride
Dosulepin impurity A (E)-3-(6,11-dihydrodibenzo[b,e]thiepin-11-ylidene)- N,N'-dimethylpropan-1-amine S-oxide
Doubleteeth pubescent angelica root
Doxapram hydrochloride
Doxapram impurity B (4RS)-1-ethyl-4-[2-[(2-hydroxyethyl)amino]ethyl]-3,3-diphenylpyrolidin-2-one
Doxazosin mesilate
Doxazosin impurity D 6,7-dimethoxyquinazoline-2,4(1H,3H)-dione
Doxazosin impurity F 2-chloro-6,7-dimethoxyquinazolin-4-amine
Doxepin hydrochloride
Doxepin for system suitability
Doxorubicin hydrochloride
Doxycycline hyclate
Doxylamine hydrogen succinate - Reference Spectrum
Doxylamine impurity A N,N-dimethyl-2-[1(RS)-1-phenyl-1-(pyridin-4-yl)ethoxy]ethanamine
Droperidol
Drospirenone
Drospirenone impurity E 3-oxo-6alpha,7alpha,15alpha,16alpha-tetrahydro-3'H,3''H-dicyclopropa [6,7:15,16]pregn-4-ene-21,17-carbolactone (17-epidrospirenone)
Duloxetine hydrochloride
Duloxetine for system suitability
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
55 mg
20 mg
20 mg
100 mg
0.1 mg
15 mg
EPY0001133
EPY0001155
New EPY0001466
EPD2954600
EPD2954500
EPY0000365
EPD2955000
EPD2957000
EPD2960000
EPY0000612
EPY0000613
EPY0000614
EPY0000726
EPY0000727
160 mg
10 mg
15 mg
150 mg
unit
30 mg
150 mg
150 mg
50 mg
10 mg
10 mg
10 mg
50 mg
5 mg
EPY0000750
EPD2962000
EPD2962005
5 mg
100 mg
50 mg
EPY0001385
EPD2963000
EPY0000208
EPY0000553
EPY0000551
EPY0000552
EPY0000838
EPY0000851
EPD2975000
EPD3000000
EPY0000163
EPY0000160
EPD3100000
EPY0001105
EPY0001115
500 mg
50 mg
10 mg
60 mg
10 mg
10 mg
5 mg
1 mg
150 mg
50 mg
unit
10 mg
150 mg
60 mg
0.06 mg
New EPY0001453
New EPY0001454
Edition 2012/2013
120 mg
40 mg
267
Table of content
European Pharmacopoeia
Code Product Unit
EPY0001455
EPY0001004
EPY0001005
EPY0001006
EPY0000249
EPY0000247
EPY0000248
EPY0001236
EPY0000254
EPE0050000
EPE0085000
EPY0000537
EPY0000512
EPE0100000
EPE0110000
EPE0109000
EPY0001211
EPY0000615
EPY0000629
EPY0000678
Duloxetine impurity A (3R)-N-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine
Dydrogesterone
Dydrogesterone impurity A 9β,10-pregna-4,6,8(14)-triene-3,20-dione
Dydrogesterone impurity B pregna-4,6-diene-3,20-dione
Ebastine - Reference Spectrum
Ebastine impurity C 4-(diphenylmethoxy)piperidine
Ebastine impurity D 1-[4-(1,1-dimethylethyl)phenyl]-4-(4-hydroxypiperidin-1-yl)butan-1-one
Econazole
Econazole for system suitability
Econazole nitrate
Eicosapentaenoic acid ethyl ester
Emedastine difumarate
Emedastine impurity E 1-(2-ethoxyethyl)-2-(hexahydro-1H-1,4-diazepin-1yl)benzimidazole
Emetine hydrochloride
Enalapril for system suitability
Enalapril maleate
Enalapril impurity mixture
Enalaprilat dihydrate
Enalaprilat for system suitability
Enalaprilat impurity G (2SR)-2-[(3SR,8aRS)-3-methyl-1,4-dioxohexahydropyrrolo [1,2-a]pyrazin-2(1H)-4-phenylbutanoic acid
Enilconazole
Enilconazole impurity E (1RS)-1-(2,4-dichlorophenyl)-2-(-1H-imidazol-1-yl)ethanol
Endotoxin standard BRP
Enoxaparin sodium
Enoxolone
Enrofloxacin
Enrofloxacin for system suitability
Entacapone
Entacapone impurity A Z isomer of entacapone
Enterokinase BRP
Ephedrine hydrochloride (racemic) Drug Precursor
Ephedrine hydrochloride Drug Precursor
4-Epianhydrotetracycline hydrochloride
4-Epidemeclocycline hydrochloride
6-Epidoxycycline hydrochloride
Epinastine hydrochloride
Epinastine hydrochloride for system suitability
4-Epioxytetracycline
Epirubicin hydrochloride
4-Epitetracycline hydrochloride
Equilin
Eq influenza Subtype 1 Strain A/eq/Newmarket/77 Horse Antiserum BRP
Eq influenza Subtype 2 American-like/Newmarket Horse Antiserum BRP
Eq Influenza Subtype 2 European-like/Newmarket Horse Antiserum BRP
10 mg
50 mg
6 mg
5 mg
unit
10 mg
10 mg
10 mg
20 mg
100 mg
200 mg
10 mg
10 mg
100 mg
20 mg
50 mg
0.06 mg
100 mg
10 mg
0.005 mg
EPY0000136
EPY0000137
EPE0150000
EPE0180000
EPE0180500
EPY0001259
EPY0001160
EPY0001249
EPY0001250
EPE0200000
EPE0305000
EPE0300000
EPE0400000
EPE0440000
EPE0500000
EPY0001139
EPY0001128
EPE0530000
EPE0550000
EPE0600000
EPY0000052
EPE0850010
EPE0850021
EPE0850022
60 mg
20 mg
10 mg
200 mg
100 mg
5 mg
10 mg
160 mg
10 mg
200 mg
50 mg
150 mg
20 mg
20 mg
50 mg
20 mg
10 mg
40 mg
100 mg
30 mg
15 mg
3x1 mg
3x1 mg
3x1 mg
268 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000712
New EPY0001325
EPE0900000
EPE1000000
EPE1100000
EPE1200000
EPY0000051
EPY0000177
EPE1300000
EPE1305000
EPE1310000
EPE1320000
EPE1400000
EPE1500000
EPE1500800
EPE1515000
EPY0000324
EPY0000338
EPY0001028
EPY0000749
EPE1600000
EPY0000852
EPY0000045
EPE1620000
EPY0000314
EPY0000046
EPE1680000
EPE1680005
EPE1700000
EPE1800000
EPY0001263
EPE1830000
EPE1840000
EPE1850000
EPY0000803
EPA1202800
EPE1860100
EPE1900000
EPY0001124
EPE2000000
EPE2150000
EPE2250000
EPE2195000
EPE2195900
EPE2202000
EPE2205500
EPY0000617
EPE2300000
EPE2400000
Edition 2012/2013
Eq Influenza Subtype 2 American-like/South Africa Horse Antiserum BRP
Equisetum palustre
Ergocalciferol
Ergometrine maleate Drug Precursor
Ergosterol
Ergotamine tartrate Drug Precursor
Erysipelas ELISA coating antigen BRP
Erythritol
Erythromycin for microbiological assay
Erythromycin A
Erythromycin B
Erythromycin C
Erythromycin estolate
Erythromycin ethylsuccinate
Erythromycin stearate
Erythropoietin BRP
Esketamine hydrochloride - Reference Spectrum
Esketamine impurity D (2R)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone ((R)-ketamine)
Esomeprazole magnesium trihydrate
Essential oil
Estradiol benzoate
Estradiol benzoate for system suitability
Estradiol butyrate
Estradiol hemihydrate
Estradiol for peak identification
Estradiol valerate
Estriol
Estriol impurity A 9,11-didehydroestriol
Estrone
Etacrynic acid
Etacrynic acid for system suitability
Etamsylate
Ethacridine lactate monohydrate
Ethambutol hydrochloride
Ethambutol for system suitability
Ethanol (anhydrous) - Reference Spectrum
Ethanol 96% - Reference Spectrum
Ethinylestradiol
Ethinylestradiol for system suitability
Ethionamide
Ethosuximide
Ethosuximide impurity A (2RS)-2-ethyl-2-methylbutanedioic acid
Ethyl acetate - Reference Spectrum
Ethylcellulose - Reference Spectrum
1-N-Ethylgaramin sulfate
1,1'-Ethylidenebistryptophan
Ethyl indole-3-carboxylate
Ethylmorphine hydrochloride - Reference Spectrum
Ethylnicotinamide
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
3x1 mg
200 mg
500 mg
50 mg
20 mg
100 mg
0.4 mg
1000 mg
250 mg
250 mg
50 mg
50 mg
100 mg
10 mg
50 mg
37.5 mg
unit
10 mg
10 mg
1000 mg
250 mg
10 mg
10 mg
100 mg
10 mg
50 mg
50 mg
20 mg
15 mg
100 mg
10 mg
30 mg
50 mg
250 mg
10 mg
unit
unit
200 mg
25.31 mg
100 mg
30 mg
30 mg
unit
unit
50 mg
2x0.00167 mg
10 mg
unit
150 mg
269
Table of content
European Pharmacopoeia
Code Product Unit
EPE2425000
EPE2450000
EPE2451000
EPE2451010
EPY0000572
EPE2470000
EPE2470050
EPY0000768
EPE2499900
EPE2499901
EPE2499914
EPE2500000
EPE2503000
EPE2503004
EPE2600000
EPY0001365
EPE5000000
EPF0005000
EPY0000382
EPY0000409
EPY0000556
EPY0000660
EPY0000731
EPY0000732
EPF0030000
EPY0000415
EPF0040000
EPF0040010
EPF0040020
EPF0041000
EPF0048000
EPF0048005
EPF0048010
EPF0048035
Ethyl parahydroxybenzoate
Etifenin
Etilefrine hydrochloride
Etilefrine impurity A 2-ethylamino-1-(3-hydroxyphenyl)ethanone
Etidronate disodium
Etodolac
Etodolac impurity H 2-(7-ethylindol-3-yl)ethanol
Etodolac for peak identification
Etofenamate
Etofenamate for peak identification
Etofenamate impurity G 2-hydroxyethyl 2-[[3-(trifluoromethyl)phenyl]amino]-benzoate
Etofylline
Etomidate
Etomidate impurity B methyl 1-[(1RS)-1-phenylethyl]-1H-imidazole-5-carboxylate
Etoposide
Etoposide for system suitability
Eugenol
Famotidine
Famotidine for system suitability
Famotidine impurity D 3-[[[2-[(diaminomethylene)amino]thiazol-4-yl]methyl]sulphanyl]propanamide
Febantel
Febantel for system suitability
Felbinac
Felbinac impurity A 4-acetyl biphenyl
Felodipine
Felypressin
Fenbendazole
Fenbendazole impurity A methyl(1H-benzimidazol-2-yl)carbamate
Fenbendazole impurity B methyl[5(6)-chlorobenzimidazol-2-yl]carbamate
Fenbufen
Fenofibrate
Fenofibrate impurity A (4-chlorophenyl)(4-hydroxyphenyl)methanone
Fenofibrate impurity B 2[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid (fenofibric acid)
Fenofibrate impurity G 1-methylethyl 2-[[2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoyl] oxy]-2-methylpropanoate
Fenoterol for peak identification
Fenoterol hydrobromide
Fentanyl - Reference Spectrum
Fentanyl for system suitability Controlled Substance
Fentanyl citrate - Reference Spectrum
Fenticonazole nitrate
Fenticonazole impurity D (RS)-1-[2-(2,4-dichlorophenyl)-2-hydroxyethyl]-3- [4-(phenyl suphanyl)benzyl]imidazolium nitrate
150 mg
25 mg
75 mg
20 mg
10 mg
60 mg
10 mg
10 mg
40 mg
15 mg
20 mg
100 mg
50 mg
25 mg
150 mg
10 mg
500 µL
100 mg
10 mg
10 mg
110 mg
10 mg
10 mg
20 mg
120 mg
0.994 mg
150 mg
20 mg
20 mg
100 mg
100 mg
20 mg
10 mg
25 mg
EPY0000756
EPF0050000
EPF0054990
New EPY0001509
EPF0055000
EPF0060000
EPF0060040
1.2 mg
100 mg
unit
25 mg
unit
50 mg
20 mg
270 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPF0100000
EPY0001013
EPY0000789
EPY0000751
Ferrous gluconate
Ferulic acid
Fexofenadine hydrochloride
Fexofenadine impurity A 2-[4-[4-[4-(hydroxydiphenylmethyl)piperidin-1-yl] butanoyl]phenyl]-2-methylpropanoic acid
Fexofenadine impurity B 2-[3-[(1RS)-1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl]phenyl]-2- methylpropanoic acid
Fexofenadine impurity C (1RS)-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]-1-[4-(1-methylethyl)phenyl]butan-1-ol
Filgrastim
Finasteride
Finasteride for system suitability
Flavoxate hydrochloride
Flavoxate impurity A 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylic acid
Flavoxate impurity B ethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate
Flecainide acetate
Flecainide impurity A 3-[2,5-bis(2,2,2-trifluoroethoxy)phenyl]-1,5,6,7,8,8a- hexahydroimidazo[1,5-a]pyridine
Flecainide impurity B (RS)-(piperidin-2-yl)methanamine
Flecainide for system suitability
Flubendazole
Flubendazole for system suitability
Flucloxacillin magnesium octahydrate
Flucloxacillin impurity C 6-aminopenicillanic acid
Flucloxacillin impurity D 3-(2-chloro-6-fluorophenyl)-5-methylisoxazole-4-carboxylic acid
Flucloxacillin impurity E 6-aminopenicillanic acid flucloxacillin amide
Flucloxacillin sodium
Fluconazole
Fluconazole for peak identification
Fluconazole impurity B 2-[2-fluro-4-(1H-1,2,4-triazol-1-yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol
Fluconazole impurity C 1,1´-(1,3-phenylene)di-1H-1,2,4-triazole
Flucytosine
Flucytosine for system suitability
Fludarabine phosphate
Fludrocortisone acetate
Flumazenil - Reference Spectrum
Flumazenil impurity B ethyl 8-hydroxy-5-methyl-6-oxo-5,6-dihydro-4H-imidazo [1,5-a][1,4]benzodiazepine-3-carboxylate
Flumequine
Flumequine impurity B ethyl(RS)-9-fluoro-5-methyl-1-oxo-6,7-dihydro-1H,5H-benzo[i,j] quinolizine-2-carboxylate
Flumetasone pivalate
Flunarizine dihydrochloride
Flunarizine dihydrochloride - Reference Spectrum
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
100 mg
20 mg
60 mg
5 mg
EPY0000752 0.01 mg
EPY0000753
EPY0001173
EPY0000090
EPY0000091
EPY0000736
EPY0000737
EPY0000738
EPF0120000
EPF0120005
5 mg
0.2 mL
60 mg
100 mg
10 mg
10 mg
10 mg
200 mg
50 mg
EPF0120010
EPY0001274
EPY0000138
EPY0000139
EPY0000892
EPY0000889
EPY0000890
EPY0000891
EPF0150000
EPY0000557
EPY0000558
EPY0000573
EPY0000574
EPF0175000
EPY0001262
EPY0000419
EPF0180000
EPF0188000
EPY0000335
25 mg
10 mg
25 mg
20 mg
5 mg
5 mg
5 mg
5 mg
250 mg
50 mg
10 mg
10 mg
5 mg
100 mg
10 mg
120 mg
100 mg
unit
5 mg
EPF0189000
EPF0189020
60 mg
0.1 mg
EPF0188500
EPF0189900
EPY0000265
Edition 2012/2013
100 mg
100 mg
unit
271
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000266
EPF0190000
EPY0000169
EPY0000443
EPY0000444
EPY0000445
EPF0200000
EPF0230000
EPY0000796
EPY0000804
EPY0000454
EPF0245000
EPF0250000
EPY0000762
EPY0000763
EPY0000764
EPY0000765
EPY0000791
EPF0253000
EPF0253020
EPF0253030
EPY0000064
EPY0000067
Flunarizine dihydrochloride for system suitability
Flunitrazepam Controlled Substance
Flunitrazepam - Reference Spectrum
Flunixin meglumine
Flunixin impurity B 2-methyl-3-(trifluoromethyl)aniline
Flunixin impurity C ethyl 2-chloropyridine-3-carboxylate
Fluocinolone acetonide
Fluocortolone pivalate
Fluorescein
Fluorescein impurity C 2-(2,4-dihydroxybenzoyl)benzoic acid
Diacetylfluorescein
Fluoresceine sodium - Reference Spectrum
Fluorouracil
Fluorouracil impurity A pyrimidine-2,4,6(1H,3H,5H)-trione (barbituric acid)
Fluorouracil impurity B dihydropyrimidine-2,4,5(3H)-trione (isobarbituric acid or 5-hydroxyuracil)
Fluorouracil impurity C pyrimidine-2,4(1H,3H)-dione (uracil)
Fluorouracil impurity F 2-ethoxy-5-fluoropyrimidin-4(1H)-one (2-ethoxy-5-fluorouracil)
Fluorouracil impurity mixture
Fluoxetine hydrochloride
Fluoxetine impurity B methyl(3-phenylpropyl)amine Controlled Substance
Fluoxetine impurity C (RS)-methyl-[3-phenyl-3-(3-trifluoromethylphenoxy)-propyl]amine
Flupentixol dihydrochloride
Flupentixol impurity D 2-[2-[4-[3-[(EZ)-2-(trifluoromethyl)-9H-thioxanthen-9-ylidene]propyl] piperazin-1-yl]ethoxy]ethanol
Flupentixol impurity F 2-[4-[(EZ)-3-[(9RS)-2-(trifluoromethyl)-9H-thioxanthen-9-yl)prop-2-enyl]- piperazin-1-yl]ethanol
Fluphenazine decanoate
Fluphenazine enantate
Fluphenazine dihydrochloride
Fluphenazine impurity mixture
Fluphenazine octanoate
Fluphenazine sulphoxide
Flurazepam monohydrochloride - Reference Spectrum
Flurbiprofen
Flurbiprofen impurity A (2RS)-2-(biphenyl-4-yl)propanoic acid
Fluspirilene
Fluspirilene impurity C 8-[4,4-bis((4-fluorophenyl)butyl]-3-(hydroxymethyl)-1- phenyl-1,3,8-triazaspiro[4.5]decan-4-one
Flutamide
Flutamide impurity C N-[4-nitro-3-(trifluoromethyl)phenyl]propanamide
Fluticasone propionate
20 mg
100 mg
unit
10 mg
10 mg
50 mg
100 mg
100 mg
120 mg
0.01 mg
100 mg
unit
40 mg
10 mg
10 mg
10 mg
10 mg
0.0002 mg
250 mg
10 mg
5 mg
100 mg
15 mg
EPY0000078 25 mg
EPF0260000
EPY0000009
EPF0280000
EPY0000708
EPY0000298
EPY0000299
EPY0000211
EPF0285200
EPF0285202
EPY0000236
EPY0000375
60 mg
100 mg
50 mg
0.07 mg
20 mg
10 mg
unit
50 mg
20 mg
20 mg
10 mg
EPF0285600
EPF0285603
EPY0000284
50 mg
20 mg
100 mg
272 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000221 Fluticasone impurity D S-methyl 6a,9a-difluoro-11b-hydroxy-16a-methyl-3-oxo-17a-propionyloxy-androsta- 1,4-diene-17β-carbothioate (S-methyl derivative)
Flutrimazole
Flutrimazole impurity B (RS)-(2-fluorophenyl)(4-fluorophenyl)phenylmethanol
Fluvastatin sodium
Fluvastatin for system suitability
Fluvoxamine maleate
Fluvoxamine for system suitability
Fluvoxamine impurity D 5-methoxy-1-[4-(trifluoromethyl)phenyl]pentan-1-one
Foeniculin for peak identification Anise oil
Folic acid
Folic acid impurity A (2S)-2-[(4-aminobenzoyl)amino]pentanedioic acid (N-(4-aminobenzoyl)-l-glutamic acid)
Folic acid impurity D 4-[[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino]benzoic acid (pteroic acid)
Formoterol fumarate dihydrate
Formoterol for impurity I identification
Formoterol fumarate for system suitability
Formylfolic acid 10-Formylfolic acid
Foscarnet sodium hexahydrate
Foscarnet impurity B disodium(ethoxyoxydophosphanyl)formate
Foscarnet impurity D Ethyl (diethoxyphosphinyl)formate
Foscarnet impurity mixture
Fosfomycin calcium
Fosfomycin sodium - Reference Spectrum
Fosfomycin trometamol
Fosinopril sodium
Fosinopril impurity A (2S,4S)-4-cyclohexyl-1-[[(R)-hydroxy(4-phenylbutyl)phosphoryl] acetyl]pyrrolidine-2-carboxylic acid
Fosinopril impurity B (2RS,4RS)-4-cyclohexyl-1-[[(RS)-[(1SR)-2-methyl-1-(1-oxopropoxy)propoxy](4- phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid
Fosinopril impurity C mixture of (2S,4S)-4-cyclohexyl-1-[[(S)-[(1S)-2-methyl-1-(1-oxopropoxy)propoxy](4- phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid and (2S,4S)-4-cyclohexyl-1-[[(R)- [(1R)-2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphoryl]acetyl]pyrrolidine-2- carboxylic acid
Fosinopril impurity D (2S,4R)-4-cyclohexyl-1-[[(R)-[(1S)-2-methyl- 1-(1-oxopropoxy)propoxy](4-phenylbutyl) phosphoryl]acetyl]pyrrolidine-2-carboxylic acid
Fosinopril impurity I [(RS)-[(1SR)-2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl) phosphoryl]acetic acid
Fosinopril impurity K (2S,4S)-4-cyclohexyl-1-(2,2-dimethyl-1-oxopropyl) pyrrolidine-2-carboxylic acid
Fosinopril impurity mixture
Framycetin sulphate
Fructose
20 mg
EPF0290000
EPF0290010
EPY0001090
EPY0001082
EPY0000854
EPY0000853
EPY0000916
EPY0000386
EPF0300000
EPY0001242
100 mg
60 mg
110 mg
0.5 mg
5 mg
1.004 mg
10 mg
100 mg
2x150mg
15 mg
EPY0001243
EPF0372000
EPY0000339
EPY0000340
EPF0380000
EPF0389000
EPF0389004
EPY0001222
EPY0001213
EPY0000782
EPF0399950
EPF0400000
EPY0001227
EPY0001228
70 mg
10 mg
10 mg
10 mg
30 mg
50 mg
10 mg
50 mg
0.012 mg
10 mg
unit
1500 mg
60 mg
5 mg
EPY0001229 5 mg
EPY0001230 10 mg
EPY0001231 10 mg
EPY0001232 5 mg
EPY0001233 5 mg
EPY0001212
EPF0450000
EPF0550000
0.02 mg
2x25 mg
100 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 273
Table of content
European Pharmacopoeia
Code Product Unit
New EPY0001399
New EPY0001413
EPF0600000
EPF0700000
New EPY0001493
EPF0702000
New EPY0001411
EPF1000000
New EPY0001394
New EPY0001384
EPY0001280
EPY0001281
EPY0001348
EPY0001349
EPG0049000
EPG0050000
EPY0001279
EPY0001190
EPY0001201
EPY0001191
EPG0100000
EPG0150000
EPY0001129
EPY0001144
EPY0000675
EPY0000676
EPY0000513
EPY0000514
EPG0200000
EPY0001363
EPY0001112
EPY0001110
EPY0001116
EPY0001012
EPY0001010
EPG0300000
EPG0325000
New EPY0001511
EPG0325010
EPY0000242
EPG0326000
EPG0326004
EPG0326012
EPY0000515
Fulvestrant
Fulvestrant for system sitability
Fumaric acid
Furosemide
Furosemide for peak identification
Furosemide impurity A 2-chloro-4-(furfurylamino)-5-sulphamoylbenzoic acid
Fusidic acid
Fusidic acid - Reference Spectrum
Fusidic acid for peak identification
Fusidic acid impurity mixture
Gabapentin
Gabapentin impurity A 2-azaspiro[4.5]decan-3-one
Gabapentin impurity B (1-cyanocyclohexyl)acetic acid
Gabapentin impurity D [1-[(3-oxo-2-azaspiro[4.5]dec-2-yl)methyl]cyclohexyl]acetic acid
Galactitol
Galactose
Galantamine hydrobromide
Galantamine natural for system suitability
Galantamine racemic mixture
Galantamine synthetic for system suitability
Gallamine triethiodide
Gammacyclodextrin
Ganciclovir
Ganciclovir impurity mixture
Gemcitabine hydrochloride
Gemcitabine impurity A 4-aminopyrimidin-2(1H)-one (Cytosine)
Gemfibrozil
Gemfibrozil for system suitability
Gentamicin sulphate
Gentamicin for peak identification
Gestodene
Gestodene for system suitability
Gestodene impurity I 13-ethyl-17-hydroxy-5-methoxy-18,19-dinor-5alpha,17alpha-pregn-15-en-20-yn-3-one
Ginkgo dry extract for peak identification
Ginkgolic Acid
Gitoxin
Glibenclamide
Glibenclamide for peak identification
Glibenclamide impurity A 4-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulphonamide
Glibenclamide impurity B methyl [[4-[2-[(5-chloro-2-methoxybenzoyl)amino]ethyl]phenyl] sulphonyl]carbamate
Gliclazide
Gliclazide impurity B 2-nitroso-octahydrocyclopenta[c]pyrrole
Gliclazide impurity F 1-(hexahydrocyclopenta[c]pyrrol-2-(1H)-yl-3-[(2-methylphenyl)sulphonyl]urea
Glimepiride
120 mg
40 mg
120 mg
100 mg
10 mg
5 mg
10 mg
unit
5 mg
0.0475 mg
300 mg
20 mg
20 mg
10 mg
50 mg
60 mg
10 mg
10 mg
10 mg
5 mg
100 mg
50 mg
220 mg
0.005 mg
50 mg
20 mg
5 mg
0.196 mg
2x25 mg
10 mg
100 mg
10 mg
0.01 mg
150 mg
20 mg
30 mg
100 mg
30 mg
10 mg
20 mg
20 mg
25 mg
50 mg
60 mg
274 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000516
EPG0340000
EPG0342000
EPY0000523
EPY0000643
EPY0001140
EPY0000191
New EPY0001406
New EPY0001381
New EPY0001407
EPG0350500
EPG0355000
EPY0000517
EPG0360000
EPG0400000
EPG0400004
New EPY0001391
EPY0000794
EPY0000795
EPG0400006
EPG0400007
EPG0400008
EPG0400101
EPG0400100
EPG0450000
EPY0001308
EPY0001309
EPY0001358
EPY0000433
EPG0460000
EPG0525000
EPY0000125
EPY0000126
New EPY0001473
EPY0000019
EPY0000194
EPG0550000
EPY0000396
EPY0000477
Glimepiride for system suitability
Glipizide
Glipizide impurity A 4-[2-(5-methylpyrazine-2-carboxamido)ethyl]benzene sulphonamide
Glipizide impurity C ethyl 2-[4-[(cyclohexylcarbamoyl)sulphamoyl]phenyl]ethyl]carbamate
Glipizide impurity D 6-methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazine-2-carboxamide
Glipizide impurity mixture
Human glucagon
Glucosamine hydrochloride
Glucosamine for system suitability
Glucosamine sulfate sodium chloride
Glucose
Glutamic acid
Glutathione
Glutethimide Controlled Substance
Glycerol (85 per cent) - Reference Spectrum
Glycerol distearate
Glycerol formal
Glycerol monocaprylate
Glycerol monocaprylocaprate
Glycerol monolinoleate
Glycerol mono-oleate
Glycerol monostearate 40-55
Glyceryl trinitrate - Reference Spectrum
Glyceryl trinitrate solution
Glycine
Glycopyrronium bromide
Glycopyrronium for peak identification
Glycopyrronium impurity N (3RS)-3-[(2RS)-(2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy]-1,1-dimethylpyrrolidinium
Ammonium glycyrrhizate
Glycyrrhizate (monoammonium)
Gonadorelin
Goserelin
Gosereline - Reference Spectrum
Goserelin for NMR identification
4-D-Ser-goserelin
Goserelin validation mixture
Gramicidin
Granisetron hydrochloride
Granisetron impurity A 2-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1] non-3-yl]-2H-indazole-3-carboxamide
Granisetron impurity B N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide
Granisetron impurity E (1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]nonan-3-amine
Griseofulvin
Guaiacol
Guaifenesin
Halofantrine hydrochloride
0.012 mg
50 mg
10 mg
10 mg
10 mg
0.002 mg
2x2.94mg
10 mg
40 mg
15 mg
100 mg
50 mg
10 mg
50 mg
unit
2000 mg
2x20 mg
400 mg
500 mg
2000 mg
2000 mg
2000 mg
unit
0.5 mL
50 mg
10 mg
10 mg
10 mg
70 mg
300 mg
5 mg
2 mg
unit
14 mg
0.1 mg
1 mg
250 mg
120 mg
1 mg
EPY0000478
EPY0000395
EPG0600000
EPY0000619
EPG0700000
EPY0000117
1 mg
2x15 mg
50 mg
2200 mg
100 mg
125 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 275
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000118
EPH0100000
New EPY0001517
New EPY0001518
EPH0100100
EPH0150000
EPY0000673
EPY0001287
EPY0001282
EPH0185000
EPH0190000
EPH0200000
EPY0001283
EPH0205010
EPY0001192
EPY0000389
EPH0210010
EPH0215000
EPH0220000
EPY0000063
EPY0000057
EPH0250000
EPH0330000
EPH0325000
EPH0400000
EPH0420000
EPH0500000
EPH0600000
EPH0700000
EPH0750000
EPH0755000
EPH0800000
EPH0830000
New EPY0001383
EPH0837000
EPH0900000
EPY0000219
EPY0000667
EPH0920000
EPH0920500
EPH0950000
EPH0990000
EPH1000000
EPY0000488
EPH1005000
EPH1100000
EPH1110000
EPY0000502
EPH1115000
Halofantrine impurity C [1,3-dichloro-6-(trifluoromethyl)phenantren-9-yl]methanol
Haloperidol
Haloperidol for system suitability
Haloperidol for peak identification
Haloperidol decanoate
Halothane - Reference Spectrum
Harpagoside
Heparin calcium for NMR identification
Heparin for Physio-Chemical Analysis
Heparin Low-Molecular-Mass for assay BRP
Heparin Low-Molecular-Mass for calibration CRS
Heparin sodium BRP
Heparin sodium for NMR identification
Hepatitis A vaccine (inactivated,absorbed) Type B BRP
Hepatitis A Vaccine (Inactivated, Non-Adsorbed)
Hepatitis B vaccine (rDNA) BRP method A (thiomersal free)
Hepatitis B vaccine (rDNA) BRP method B
Hepatitis C Virus RNA for NAT testing BRP
Heptadecanol
Heptaminol hydrochloride
Heptaminol impurity A (2RS)-6-methylhept-5-en-2-amine
alpha-Hexachlorocyclohexane
Hexamidine diisetionate
Hexetidine
Hexobarbital
Hexylresorcinol
Hide Powder
Histamine dihydrochloride
Histamine phosphate
Histidine
Histidine hydrochloride monohydrate
Homatropine hydrobromide
Homatropine methylbromide
Homatropine methylbromide for system suitability
L-Homocycsteine thiolactone hydrochloride - Reference Spectrum
Human albumin for electrophoresis BRP
Human anti-D immunoglobulin BPR
Human coagulation factor VII concentrate BRP
Human coagulation factor VIII concentrate BRP
Human coagulation factor IX concentrate BRP
Human hepatisis A immunoglobulin BRP
Human immunoglobulin BRP
Human immunoglobulin for electrophoresis BRP
Human immunoglobulin (molecular size) BRP
Human Plasma Pools for NAT Validation
Human rabies immunoglobulin BRP
Human tetanus immunoglobulin BRP
Human vaccinia immunoglobulin
Hyaluronidase BRP
10 mg
50 mg
25 mg
25 mg
60 mg
unit
1.03 mg
30 mg
300 mg
5x1 mg
25 mg
2 mL
30 mg
3x0.5 mL
3x0.8 mL
2x0.5 mL
2x1 mL
5x40 mg
2x600 mg
150 mg
20 mg
10 mg
50 mg
100 mg
500 mg
100 mg
500 mg
250 mg
250 mg
100 mg
100 mg
100 mg
25 mg
5 mg
unit
1 mL
unit
2x26 mg
5x37 mg
5x30 mg
3x10 mg
15800 mg
96 mg
3x700 mg
3502 mg
3x170 mg
87 mg
3x1 mL
50 mg
276 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPH1120000
EPY0001151
EPH1200000
New EPY0001494
EPY0000646
EPY0000710
EPH1300000
EPY0001092
EPH1400000
New EPY0001482
EPH1425000
EPH1426000
EPY0000446
EPB0650000
EPH1428000
EPY0000119
EPH1429400
EPY0001322
EPY0001277
EPH1429700
EPH1430000
EPY0000186
EPH1435000
EPY0000011
EPY0000012
EPY0000013
EPY0000483
EPY0000484
Hydralazine hydrochloride
Hydrastine hyrochloride
Hydrochlorothiazide
Hydrochlorothiazide for peak identification
Hydrocodone hydrogen tartrate 2.5-hydrate Controlled Substance
Hydrocodone for peak identification Controlled Substance
Hydrocortisone
Hydrocortisone for peak identification
Hydrocortisone acetate
Hydrocortisone acetate for peak identification
Hydrocortisone hydrogen succinate
Hydrogenated wool fat
Hydromorphone hydrochloride Controlled Substance
Hydrous benzoyl peroxide - Reference Spectrum
Hydroxocobalamin
Hydroxycarbamide
Hydroxyethyl salicylate
Hydroxyethyl starch (high Mw)
Hydroxyethyl starch (medium MW)
4-Hydroxyphenoxymethylpenicillin potassium
D-alpha-(4-Hydroxy-phenyl)glycine (2R)-2-amino-2-(4-hydroxyphenyl)acetic acid - Cefadroxyl impurity A
Hydroxypropylbetadex
Hydroxyzine hydrochloride
Hymecromone
Hymecromone impurity A Resorcinol
Hymecromone impurity B 7-hydroxy-2-methyl-4H-1-benzopyran-4-one
Hyoscine
Hyoscine impurity A (1R,2R,4S,5S,7s)-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl (2S)-3-hydroxy-2- phenylpropanoate (norhyoscine)
Hyoscine butylbromide
Hyoscine butylbromide impurity E (1R,2R,4S,5S,7S)-9-butyl-7-[[(2S)-3-hydroxy-2-phenylpropanoyl]oxy]-3-oxa- 9-azoni atricyclo[3.3.1.02,4]nonane
Hyoscine hydrobromide
Hyoscine hydrobromide impurity B (1R,2R,4S,5S,7s)-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl(2S)- 3-hydroxy-2-phenylpropanoate
Hyoscyamine sulfate
Hyoscyamine impurity E (1R,3s,5S)-8-azabicyclo[3.2.1] oct-3-yl(2S)-3-hydroxy-2-phenylpropanoate
Hypromellose phthalate
Ibuprofen
Ibuprofen impurity B (2RS)-2-(4-Butylphenyl)propionic acid (0,06% solution in Acetonitrile)
Ibuprofen impurity F 3-[4-(2-methylpropyl)phenyl]propanoic acid
Ibuprofen for peak identification
Idoxuridine
Ifosfamide
Ifosfamide - Reference Spectrum
20 mg
20 mg
160 mg
10 mg
10 mg
10 mg
100 mg
5 mg
125 mg
15 mg
100 mg
250 mg
10 mg
unit
10 mg
175 mg
125 mg
800 mg
1200 mg
20 mg
50 mg
10 mg
600 mg
100 mg
25 mg
25 mg
10 mg
10 mg
EPH1450000
EPY0000447
20 mg
10 mg
EPH1500000
EPY0000448
50 mg
10 mg
EPH1600000
EPY0000449
EPY0000915
EPI0020000
EPB1220000
EPY0000140
EPY0000881
EPI0050000
EPI0060000
EPI0060100
100 mg
10 mg
10 mg
250 mg
1.15 mL
5 mg
0.09 mg
50 mg
50 mg
unit
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 277
Table of content
European Pharmacopoeia
Code Product Unit
EPI0060002
EPI0060004
EPI0060010
EPI0060012
EPI0086000
EPI0090000
EPI0100000
EPY0000893
EPY0001153
EPY0000540
EPY0001205
EPI0150000
EPI0150020
EPY0000788
EPY0000880
EPY0000746
EPI0200000
EPY0000349
EPI0305000
EPI0310000
EPY0000348
EPI0320000
EPI0320300
EPI0320301
EPY0001101
EPI0320330
EPI0320331
EPI0328000
EPY0000839
EPY0001294
EPY0001292
Ifosfamide impurity A 3-[(2-chloroethyl)amino]propyl dihydrogen phosphate
Ifosfamide impurity B bis[3-[(2-chloroethyl)amino]propyl]dihydrogen diphosphate
Ifosfamide impurity E 3-chloro-N-(2-chloroethyl)propan-1-amine
Ifosfamide impurity F (RS)-2-chloro-3-(2-chloroethyl)-1,3,2-oxazaphosphinane 2-oxide
Imidazole
Imipenem
Imipramine hydrochloride
Imipramine for system suitability
Immunoglobulin for anti-A, anti-B antibodies limit test
Immunoglobulin panel for anti-D antibodies test BRP
Imperatorin
Indapamide
Indapamide impurity B 4-chloro-N-(2-methyl-1H-indol-1-yl)-3-sulphamoylbenzamide
Indinavir
Indinavir sulfate - Reference Spectrum
Indinavir for system suitability
Indometacin
Insulin aspart
Insulin (bovine)
Insulin (human)
Insulin lispro
Insulin (porcine)
Interferon alfa-2a
Interferon alfa-2b
Interferon beta-1a
Interferon gamma 1b
Interferon gamma-1b validation solution
Iobenguane sulfate
Iobenguane sulphate - Reference Spectrum
Iodixanol
Iodixanol impurity C 5-[acetyl[3-[[3,5-bis[(2,3-dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl]amino]-2- hydroxypropyl]amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide
Iodixanol impurity E 5-[acetyl[3-[acetyl[3-carbamoyl-5-[(2,3-dihydroxypropyl)carbamoyl]-2,4,6- triiodophenyl]amino]-2-hydroxypropyl]amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6- triiodobenzene-1,3-dicarboxamide
Iodixanol impurity H 5-[acetyl[3-[acetyl[3-[[3-[3-[acetyl[3,5-bis[(2,3-dihydroxypropyl)carbamoyl]-2,4,6- triiodophenyl]amino]-2-hydroxypropoxy]-2-hydroxypropyl]carbamoyl]-5-[(2,3- dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl]amino]-2-hydroxypropyl]amino]-N,N'-bis(2,3- dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide
Iohexol
Iohexol impurity A 5-acetamido-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-tri-iodobenzene-1,3- dicarboxamide
Iohexol impurity J 5-amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-tri-iodobenzene-1,3-dicarboxamide
Iohexol for peak identification
Iopamidol
Iopamidol impurity A N,N'-bis[2-hydroxy-1-(hydroxymethyl)ethy]-5-amino-2,4,6-tri-iodoisophthalamide
2x100 mg
20 mg
2x10 mg
10 mg
100 mg
100 mg
50 mg
10 mg
45 mg
unit
20 mg
150 mg
5 mg
100 mg
unit
20 mg
50 mg
8 mg
7.99 mg
8 mg
5.93 mg
8.61mg
1 mL
200 µL
0.5 mL
2x0.5 mL
0.2 mL
25 mg
unit
60 mg
10 mg
EPY0001291 10 mg
EPY0001293 10 mg
EPI0320800
EPI0320810
EPI0320820
EPY0000672
EPI0329000
EPI0329010
150 mg
50 mg
125 mg
10 mg
50 mg
10 mg
278 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000406 Iopamidol impurity H 4-chloro-N,N'-bis(2-hydroxy-1-(hydroxymethyl)ethyl)-5- (2-hydroxypropanoyl)amino)2,6-diiodobenzenz-1,3-dicarboxamide
Iopanoic acid
Iopentol
Iopromide
Iopromide impurity A 5-amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-N-methylbenzene-1,3- dicarboxamide
Iopromide for system suitability 1
Iopromide for system suitability 2
Iotalamic acid
Iotalamic acid impurity A 5-Amino-2,4,6-tri-iodo-N-methylisophthalamic acid
Iotrolan
Iotrolan for system suitability
Ioxaglic acid
Ioxaglic acid impurity A 3-amino-5-[(2-hydroxyethyl)carbamoyl]-2,4,6-triiodobenzoic acid
Ipratropium bromide
Ipratropium impurity A (1R,3r,5S,8r)-3-hydroxy-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane
Ipratropium bromide impurity B (1R,3r,5S,8s)-3-[[(2RS)-3-hydroxy-2-phenylpropanoyl]oxy]-8-methyl-8-(1-methylethyl)-8- azoniabicyclo[3.2.1]octane
Irbesartan
Irbesartan impurity A 1-(pentylamino)-N-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]cyclopentanecarboxamide
Isoconazole
Isoconazole nitrate
Isoemetine hydrobromide
Isoflurane
Isoflurane - Reference Spectrum
Isoleucine
Isomalt
Isomaltooligosaccharide
Isoniazid
Isoprenaline hydrochloride
Isoprenaline sulfate
Isopropyl hexadecanoate
Isopropyl tetradecanoate
Isosorbide dinitrate
Isosorbide mononitrate
Isosorbide-2-nitrate
Isotretinoin
Isotretinoin for peak identification
Isoxsuprine hydrochloride
Isradipine
Isradipine impurity D methyl 1-methylethyl 4-(2,1,3-benzoxadiazol-4-yl)-2,6-dimethylpyridine-3,5-dicarboxylate
Itraconazole
Itraconazole for system suitability
Ivermectin
Ivy leaf standardised tincture
Josamycin
10 mg
EPI0330000
EPY0001297
EPY0001020
EPY0001077
EPY0001021
EPY0001022
EPI0340000
EPA0560000
EPY0000555
EPY0000658
EPY0000141
EPY0000142
EPI0360000
EPY0000276
EPI0361000
100 mg
10 mg
100 mg
0.125 mg
5 mg
5 mg
150 mg
20 mg
100 mg
5 mg
125 mg
20 mg
120 mg
10 mg
10 mg
EPY0001166
EPY0001156
EPI0375000
EPI0380000
EPI0400000
EPY0000858
EPY0000037
EPI0460000
EPI0465000
EPY0000070
EPI0500000
EPI0599990
EPI0600000
EPI0725000
EPI0750000
EPI0775000
EPI0775010
EPI0775020
EPI0800000
New EPY0001218
EPI0900000
EPY0000366
EPY0000367
EPI7000000
EPY0001100
EPI8000010
EPY0000575
EPY0000041
60 mg
10 mg
200 mg
200 mg
25 mg
1.5 mL
unit
50 mg
3000 mg
0.9 mg
100 mg
50 mg
500 mg
100 mg
2 mL
300 mg
100 mg
50 mg
60 mg
10 mg
50 mg
125 mg
5 mg
150 mg
15 mg
150 mg
2 mL
150 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 279
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000042
EPY0001315
EPK0100000
EPK0200000
EPY0000450
EPK0551000
EPY0000246
EPY0000244
EPY0000245
EPK0600000
EPK1000000
EPK2000000
EPK2000010
EPK2000015
EPY0000486
EPY0000626
EPY0000164
EPY0000161
New EPY0001200
EPL0050000
EPL0129000
EPY0000257
EPA1206000
EPL0100000
EPL0130000
EPY0000188
EPY0000425
EPY0000518
EPY0000426
EPY0001030
EPY0001031
EPY0001085
EPY0001032
EPY0000773
EPY0000774
New EPY0001474
EPY0000654
EPY0000487
EPY0000674
EPY0000685
EPL0375000
EPL0376000
EPL0376001
EPY0000047
EPL0380000
EPY0000048
Josamycin propionate
Josamycin for peak identification
Kanamycin B sulfate
Kanamycin monosulfate
Ketamine hydrochloride Controlled Substance
Ketamine impurity A 1-[(2-chlorophenyl)(methylimino)methyl]cyclopentanol
Ketobemidone hydrochloride - Reference Spectrum
Ketobemidone impurity B B 1-[4-(3-hydroxyphenyl)-1-methylpiperidin-4-yl]ethanone
Ketobemidone impurity C 1-[4-(3-hydroxyphenyl)piperidin-4-yl]propan-1-one
Ketoconazole
3-Ketofusidic acid
Ketoprofen
Ketoprofen impurity A 1-(3-benzoylphenyl)ethanone
Ketoprofen impurity C 3-[(1RS)-1-carboxyethyl]benzoic acid
Ketorolac trometamol
Ketorolac trometamol for peak identification
Ketotifen hydrogen fumarate - Reference Spectrum
Ketotifen impurity G 4-(1-methylpiperidin-4-ylidene)-4H-benzo(4,5)cyclohepta(1,2-b)thiophen-9,10-dione
Kudzuvine root dry extract
Labetalol hydrochloride
Lactitol monohydrate
Lactobionic acid
Lactose (anhydrous)
Lactose
Lactulose
Lactulose for system suitability
Lamivudine
Lamivudine for system suitability 1
Lamivudine for system suitability 2
Lamotrigine
Lamotrigine for peak identification
Lamotrigine for system suitability
Lamotrigine impurity E 2,3-dichlorobenzoic acid
Lansoprazole
Lansoprazole for peak identification
Lauric acid
Leflunomide
Leflunomide impurity A 4-(trifluoromethyl)aniline
Leflunomide for peak identification
Letrozole
Leucine
Leuprorelin
Leuprorelin - Reference Spectrum
Levamisole hydrochloride for system suitability
Levamisole hydrochloride
Levamisole - Reference Spectrum
150 mg
25 mg
20 mg
150 mg
10 mg
50 mg
unit
5 mg
5 mg
150 mg
10 mg
50 mg
10 mg
5 mg
10 mg
5 mg
unit
0.0225 mg
200 mg
80 mg
60 mg
100 mg
100 mg
100 mg
3000 mg
12 mg
150 mg
10 mg
10.3 mg
10 mg
20 mg
10 mg
10 mg
60 mg
1 mg
1500 mg
100 mg
25 mg
1 mg
70 mg
50 mg
1 mg
unit
60 mg
50 mg
unit
280 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0001253
EPY0001254
EPY0001255
EPY0001256
EPY0001257
EPL0390000
EPL0390008
Levetiracetam
Levetiracetam impurity A (2RS)-2-(2-oxopyrrolidin-1-yl)butanoic acid
Levetiracetam impurity B (2Z)-2-(2-oxopyrrolidin-1-yl)but-2-enamide
Levetiracetam impurity C pyridin-2-ol
Levetiracetam impurity D (2R)-2-(2-oxopyrrolidin-1-yl)butanamide ((R)-etiracetam)
Levocabastine hydrochloride
Levocabastine impurity D 1-[cis-4-cyano-4-(4-fluorophenyl)cyclohexyl]-
4-phenylpiperidine-4-carboxylic acid
Levocarnitine
Levocarnitine impurity A (E)-or(Z)-4-(trimethylammonio)but-2-enoate
Levodopa
Levodropropizine
Levodropropizine impurity A (2R)-3-(4-phenylpiperazin-1-yl)propane-1,2-diol(dextrodropropizine)
Levodropropizine impurity B 1-phenylpiperazine
Levodropropizine impurity C 2,3-epoxypropan-1-ol
Levomepromazine hydrochloride
Levomepromazine maleate
Levonorgestrel
Levonorgestrel impurity B 13-ethyl-17-hydroxy-18,19-dinor-17-alpha-pregn-5(10)-en-20-yn-3-one
Levonorgestrel for system suitability
Levothyroxine for peak identification
Levothyroxine sodium
Lidocaine
Lidocaine hydrochloride
Lincomycin chlorhydrate for system suitability
Lincomycin hydrochloride
Liothyronine sodium
Liothyronine for peak identification
Lisinopril for system suitability
Lisinopril dihydrate
Lisinopril impurity F (2S)-1-[(2S)-6-amino-2-[[(1S)-1-carboxy-3-cyclohexylpropyl]amino]hexanoyl]pyrrolidine- 2-carboxylic acid (cyclohexyl analogue)
Lithium clavulanate
Lithocholic acid
Lobeline hydrochloride
Lomustine
Loperamide hydrochloride
Loperamide hydrochloride for system suitability
Loperamide oxide monohydrate
Lopinavir for system suitability
Loratadine
Loratadine for system suitability
110 mg
10 mg
10 mg
10 mg
10 mg
125 mg
20 mg
EPL0399900
EPL0399905
EPL0400000
EPL0420000
EPL0420002
EPY0001033
EPY0001048
EPL0500000
EPL0505000
EPL0551000
New EPY0001379
New EPY0001431
New EPY0001382
EPL0570000
EPL0595000
EPL0600000
New EPY0001393
EPL0650000
EPL0700000
EPY0000860
EPY0001235
EPL0702000
EPY0001234
125 mg
50 mg
100 mg
60 mg
20 mg
50 mg
300 mg
100 mg
50 mg
30 mg
10 mg
10 mg
10 mg
100 mg
50 mg
100 mg
10 mg
250 mg
50 mg
0.0046 mg
2 mg
50 mg
0.01 mg
EPL0720000
EPL0720800
EPY0000112
EPL0745000
EPL0750000
EPY0000322
EPY0000341
New EPY0001505
EPY0000688
EPY0000603
125 mg
60 mg
50 mg
50 mg
50 mg
15 mg
20 mg
10 mg
60 mg
20 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 281
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000604 Loratadine impurity F ethyl 4-[(11RS)-8-chloro-11-fluoro-6,11-dihydro-5H-benzo[5,6]cyclohepta [1,2-b]pyridin-11-yl]piperidine-1-carboxylate
Loratadine impurity H ethyl 4-oxopiperidine-1-carboxylate
Lorazepam Controlled Substance
Lorazepam for system suitability Controlled Substance
Lorazepam impurity D (5RS)-7-chloro-5-(2-chlorophenyl)-4,5-dihydro-1H- 1,4-benzodiazepine-2,3-dione
Losartan potassium
Losartan impurity D 2-butyl-4-chloro-1H-imidazole-5-carbaldehyde
Losartan for system suitability
Lovastatin
Lovastatine for peak identification
Lufenuron
Lufenuron for peak identification
Lufenuron impurity G 2,5-dichloro-4-[[[(2,6-difluorophenyl)carbonyl]carbamoyl] amino]phenyl phenyl carbonate
Lynestrenol
Lynestrenol for peak identification
Lysine acetate
Lysine hydrochloride
Macrogol 30 dipolyhydroxystearate
Macrogol 40 sorbitol heptaoleate
Macrogol polyvinyl alcohol grafted polymer
Magnesium aspartate dihydrate
Magnolol
Malathion
Malathion impurity A diethyl(2RS)-2-[(methoxy)(methylsulfanyl)-S-phosphinothioyl] butane dioate
Malathion impurity B diethyl(2RS)-2-(dimethoxy-S-phosphinothioyl)-butanedioate
Maleic acid
Malic acid - Reference Spectrum
Maltitol
Mannitol
Maprotiline hydrochloride
Maprotiline impurity D 3-(9,10-dihydro-9,10-ethanoanthracen-9-yl)-N-methylprop-2-en-1-amine
Marbofloxacin
Marbofloxacin for peak identification
Measles vaccine (live) BRP
Mebendazole
Mebendazole for system suitability
Mebendazole - Reference Spectrum
Mebrofenin
Meclozine dihydrochloride
Meclozine impurity B 4-chlorobenzhydrol
Meclozine impurity H 1-(4-chlorobenzhydryl)piperazine
10 mg
EPY0000605
EPL0750500
EPY0000576
EPY0000718
50 mg
100 mg
0.8 mg
10 mg
EPY0001062
EPY0001072
EPY0001076
EPL0790000
EPY0001136
EPY0001284
EPY0001261
EPY0001265
50 mg
6 mg
0.0015 mg
60 mg
20 mg
140 mg
0.4028 mg
15 mg
EPL0800000
EPY0001034
EPY0000397
EPL0900000
EPY0001369
EPY0000745
EPY0001157
EPM0088000
New EPY0001289
EPM0120000
EPM0120005
50 mg
20 mg
60 mg
50 mg
100 mg
20 mg
400 mg
60 mg
20 mg
250 mg
10 mg
EPM0120010
EPM0100000
EPY0000143
EPM0160000
EPM0200000
EPM0206000
EPM0206040
EPY0000819
EPY0000820
EPM0210000
EPM0215000
EPY0000144
EPY0000168
EPY0001086
EPM0220000
EPY0001310
EPY0001311
10 mg
100 mg
unit
1200 mg
1200 mg
100 mg
25 mg
10 mg
20 mg
5 uc
20 mg
20 mg
unit
120 mg
150 mg
15 mg
15 mg
282 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPM0240000
EPY0001107
EPY0001106
EPM0250000
EPM0250010
EPY0000598
EPM0252600
EPY0001081
EPM0253000
EPM0260100
New EPY0001524
New EPY0001507
EPY0001209
EPY0001080
EPY0001035
EPY0001036
EPY0001037
Medronic acid
Medronic acid impurity A Tris(1-methylethoxy)phosphane
Medronic acid impurity B Tetrakis(1-methylethyl)methhylenediphosphonate
Medroxyprogesterone acetate
Medroxyprogesterone acetate for performance test
Medroxyprogesterone acetate for system suitability
Mefenamic acid
Mefenamic acid impurity A 2,3-dimethylaniline
Mefloquine hydrochloride
Megestrol acetate - Reference Spectrum
Megestrol acetate for system suitability
Megestrol acetate for peak identification
Meglumine
Meloxicam
Meloxicam impurity A ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide
Meloxicam impurity B 5-methylthiazol-2-amine
Meloxicam impurity C N-[(2Z)-3,5-dimethylthiazol-2(3H)-ylidene]-4-hydroxy-2-methyl-2H-1,2- benzothiazine-3-carboxamide 1,1-dioxide
Meloxicam impurity D N-[(2Z)-3-ethyl-5-methylthiazol-2(3H)-ylidene]-4-hydroxy-2-methyl-2H-1,2- benzothiazine-3-carboxamide 1,1-dioxide
Melphalan - Reference Spectrum
Melphalan for system suitability
Melphalan hydrochloride
Menadione
Menthol
Mepivacaine hydrochloride
Mepivacaine impurity B (RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide
Meprobamate Controlled Substance
Mepyramine maleate
Mepyramine impurity A N-(4-methoxybenzyl)pyridin-2-amine
Mepyramine impurity C pyridin-2-amine
Meropenem trihydrate
Mesalazine
Mesityl oxid
Mesna - Reference Spectrum
Mesna impurity C 2-(Acetylsulphanyl)ethanesulphonic acid
Mesna impurity D 2,2'-(disulphanediyl)bis(ethanesulphonic acid)
Meso-rich exametazime
Mesterolone
Mesterolone impurity A 17β-hydroxy-1alpha-methylandrost-4-en-3-one
Mestranol
Metacresol - Reference Spectrum
Metacycline hydrochloride
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
20 mg
60 µl
40 µl
100 mg
50 mg
10 mg
50 mg
100 mg
100 mg
unit
50 mg
25 mg
10 mg
50 mg
5 mg
5 mg
5 mg
EPY0001039 5 mg
New EPY0001513
New EPY0001457
New EPY0001158
EPM0300000
EPM0350000
EPM0370000
EPM0370020
EPM0400000
EPM0500000
EPY0000679
EPY0000680
EPY0001252
EPY0000297
EPY0001040
EPY0000337
EPY0000316
EPY0000317
EPY0000227
EPY0000097
EPY0000096
EPM0600000
EPY0000301
EPM0600500
Edition 2012/2013
unit
10 mg
100 mg
100 mg
150 mg
100 mg
60 mg
100 mg
1000 mg
10 mg
10 mg
110 mg
125 mg
100 mg
unit
10 mg
10 mg
0.5 mg
60 mg
30 mg
100 mg
unit
50 mg
283
Table of content
European Pharmacopoeia
Code Product Unit
EPM0600900
EPM0600905
New EPY0001481
EPM0605000
EPY0000770
EPY0000323
EPM0610000
EPM0610030
EPM0620000
EPM0630000
EPM0800000
EPY0000428
EPM0900000
EPY0000754
EPM0950000
EPM0960000
EPM1000000
EPY0000602
EPY0000663
Metamizole sodium
Metamizole impurity A 4-formylamino-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one
Metamizole impurity E 4-N-Demethylanalgin
Metformin hydrochloride
Methacrylic acid-ethylacrylate copolymer (1:1) - type A
Methacrylic acid-ethyl acrylate copolymer (1:1) - type B
Methacrylic acid-ethylacrylate copolymer (1:1) - Reference Spectrum
Methacrylic acid-ethyl acrylate copolymer (1:1), dispersion 30% - Reference Spectrum
Methacrylic acid-methylmethacrylate copolymer (1:1) - Reference Spectrum
Methacrylic acid-methylmethacrylate copolymer (1:2) - Reference Spectrum
Methadone hydrochloride - Reference Spectrum
Methanol - Reference Spectrum
Methaqualone - Reference Spectrum
Methenamine
DL-Methionine
Methionine
Methotrexate
Methotrexate for peak identification
Methotrexate impurity C (2S)-2-[[4-[[(2-amino-4-oxo-1,4-dihydropteridin-6- yl)methyl]methylamino]benzoyl]amino]pentanedioic acid (N-methylfolic acid, methopteridine)
Methotrexate impurity D 4-[[(2-amino-4hydroxypteridin-6-yl)methyl]methyl-amino]benzoic acid
Methotrexate impurity E 4-[[(2,4-diaminopteridin-6-yl)methyl]methylamino]benzoic acid (4-amino-N10-methylpteroic acid, APA)
Methylatropine bromide
Methylatropine nitrate
Methylcarbidopa
Methyl 2-(4-chlorophenoxy)-2-methylpropionate
Methyldopa
Racemic methyldopa
Methyldopa for system suitability
Methylene chloride
2-(1-Methylethyl)pentanoic acid
Methyl 12-hydroxystearate
Methyl nicotinate
Methylergometrine maleate
Methylergometrine for system suitability
Methylnitrosoindoline
Methyl parahydroxybenzoate
Methylphenidate hydrochloride Controlled Substance
Methylphenidate impurity mixture
Methylphenobarbital Controlled Substance
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone hydrogen succinate
Methylprednisolone hydrogen succinate for performance test
2-Methylpyrazine
N-Methylpyrrolidone - Reference Spectrum
100 mg
15 mg
15 mg
50 mg
200 mg
200 mg
unit
unit
unit
unit
unit
unit
unit
10 mg
50 mg
50 mg
100 mg
20 mg
10 mg
EPM1000008
EPY0000664
10 mg
10 mg
EPM1300000
EPM1400000
EPM1450000
EPM1470000
EPM1500000
EPY0001374
EPY0001083
EPM1550000
EPM1551000
EPM1556000
EPY0000398
EPY0000776
EPY0000777
EPM1625000
EPM1650000
EPY0001017
EPY0000910
EPM1700000
EPM1750000
EPM1755000
EPM1755200
EPM1755220
New EPY0001376
EPY0000190
100 mg
100 mg
1 mg
0.5 mL
50 mg
5 mg
0.024 mg
2 mL
25 mg
100 mg
25 mg
10 mg
0.53 mg
110 mg
150 mg
40 mg
0.04 mg
500 mg
150 mg
100 mg
125 mg
50 mg
100 mg
unit
284 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPM1770180
EPY0000418
EPY0000407
EPM1770200
EPM1800000
EPY0000861
EPM1800900
EPM1800902
EPM1808000
EPM1824990
EPM1825000
EPM1824995
EPM1825010
EPY0000701
EPY0000702
EPY0000171
EPM1830000
EPY0000145
EPM1845000
EPM1850000
EPM1851000
EPY0000069
EPY0000087
EPM1860000
EPY0000202
EPY0000203
EPM1875000
EPY0001041
Methyl ricinoleate
Methylrosanilinium chloride
Methylrosanilinium chloride for system suitability
Methyl stearate
Methyltestosterone
Methyltestosterone for system suitability
Methylthioninium chloride
Methylthioninium impurity A 3-(dimethylamino)-7-(methylamino)phenothiazin-5-ylium
Metixene hydrochloride
Metoclopramid
Metoclopramide hydrochloride
Metoclopramide impurity A 4-(acetylamino)-5-chloro-N-(2-diethylaminoethyl)-2-methoxy benzamide
Metoclopramide impurity E N,N-diethylethane-1,2-diamine
Metolazone
Metolazone for system suitability
Metoprolol succinate - Reference Spectrum
Metoprolol tartrate
Metoprolol impurity A (2RS)-1-(ethylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol
Metrifonate
Metronidazole
Metronidazole benzoate
Metronidazole benzoate - Reference Spectrum
Metronidazole impurity A 2-methyl-4-nitroimidazole
Mexiletine hydrochloride
Mexiletine impurity C 1,1'-[(3,3',5,5'-tetramethylbiphenyl-4,4'-diyl)bisoxy]dipropan-2-amine
Mexiletine impurity D (2RS)-2-(2,6-dimethylphenoxy)propan-1-amine
Mianserin hydrochloride
Mianserin impurity B (14bRS)-2-methyl-1,2,3,4,10,14b-hexahydrodibenzo[c,f] pyrazino[1,2-a]azepine-8-sulfonic acid
Mianserin hydrochloride for system suitability
Miconazole
Miconazole nitrate
Midazolam Controlled Substance
Midazolam impurity C acide 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo [1,5-a][1,4]benzodiazepine-3-carboxylique
Midazolam for system suitability Controlled Substance
Milk thistle standardised dry extract
Minocycline hydrochloride
Minoxidil
Minoxidil for system suitability
Mirtazapine
Mirtazapine for system suitability
Misoprostol
Misoprostol for system suitability
Mitomycin
125 mg
40 mg
10 mg
100 mg
100 mg
10 mg
50 mg
20 mg
75 mg
100 mg
50 mg
25 mg
20 mg
80 mg
10 mg
unit
60 mg
10 mg
100 mg
50 mg
50 mg
unit
10 mg
100 mg
2 mg
2 mg
100 mg
10 mg
EPY0000862
EPM1880000
EPM1900000
EPM2200000
EPY0000562
1.01 mg
70 mg
100 mg
50 mg
0.08 mg
EPY0000599
EPY0000539
EPM2280000
EPM2300000
New EPY0001432
EPY0000705
EPY0000721
EPY0000490
EPY0001162
EPY0000378
1 mg
120 mg
125 mg
50 mg
10 mg
10 mg
10 mg
60 mg
5 mg
120 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 285
Table of content
European Pharmacopoeia
Code Product Unit
EPM2305000
EPM2305005
EPY0000635
EPY0000636
EPY0000251
EPY0000821
EPY0000822
EPY0000823
EPM2900000
New EPY0001436
New EPY0001435
New EPY0001433
New EPY0001434
EPY0000028
EPY0000451
EPY0000452
EPY0000830
EPY0000772
EPY0000747
EPY0000703
EPY0000717
EPY0000226
EPY0000222
EPM3600000
EPM3805000
EPM3805500
EPM3806000
EPY0000489
EPY0000519
EPY0000692
EPY0000690
EPY0000691
EPY0000689
EPY0000485
New EPY0001484
EPN0020000
EPN0020020
EPN0020030
EPY0000146
EPY0001215
EPN0025000
EPY0000077
EPY0000120
EPY0000121
Mitoxantrone hydrochloride
Mitoxantrone impurity A 1-amino-5,8-dihydroxy-4-[[2-[(2-hydroxyethyl)amino]ethyl]amino]anthracene-9,10-dione
Modafinil
Modafinil for system suitability
Molgramostim
Molsidomine
Molsidomine impurity B N-Nitrosomorpholine
Molsidomine impurity D morpholine-4-carbaldehyde
Mometasone furoate
Montelukast dicyclohexylamine
Montelukast for peak identification
Montelukast racemate
Montelukast sodium
Morantel hydrogen tartrate
Morphine hydrochloride (trihydrate) Controlled Substance
Morphine sulphate Controlled Substance
Morphine for system suitability Controlled Substance
Moxidectin
Moxidectin for system suitability
Moxifloxacin hydrochloride
Moxifloxacin for peak identification
Moxonidine
Moxonidine impurity A 4,6-dichloro-N-(imidazolidin-2-ylidene)-2-methylpyrimidin-5-amine
Mumps vaccine (live) BRP
Mupirocin - Reference Spectrum
Mupirocin calcium - Reference Spectrum
Mupirocin lithium
Mycophenolate mofetil
Mycophenolate mofetil for peak identification
Mycoplasma fermentans BRP
Mycoplasma hyorhinis BRP
Mycoplasma orale BRP
Mycoplasma synoviae BRP
Myo-inositol
Medroxyprogesterone acetate for peak identification
Nabumetone
Nabumetone impurity D (E)-4-(6-methoxynaphthalen-2-yl)but-3-en-2-one
Nabumetone impurity F 6,6'-dimethoxy-2,2'-binaphthalenyl
Nadolol
Nadolol impurity mixture
Nadroparin calcium
Naftidrofuryl - Reference Spectrum
Naftidrofuryl impurity A 2-[(naphtalen-1-yl)methyl]-3-(tetrahydrofuran-2-yl)propanoic acid
Naftidrofuryl impurity B ethyl 2-[(naphtalen-1-yl)methyl]-3-(tetrahydrofuran-2-yl)propanoate
50 mg
5 mg
110 mg
0.1 mg
0.3 mL
5 mg
10 mg
10 mg
100 mg
150 mg
20 mg
20 mg
150 mg
50 mg
25 mg
40 mg
15 mg
70 mg
10 mg
110 mg
10 mg
50 mg
10 mg
5x33 mg
unit
unit
100 mg
30 mg
10 mg
1 mL
1 mL
1 mL
1 mL
1020 mg
25 mg
60 mg
10 mg
10 mg
100 mg
0.01 mg
250 mg
unit
10 mg
25 mg
286 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000331 Naftidrofuryl impurity F 2-[(diethylamino)ethyl 2-[(naphthalen-2-yl)methyl]-3- (tetrahydrofuran-2-yl)propanoate
Nalidixic acid
Naloxone hydrochloride dihydrate
Naloxone for peak identification
Naltrexone hydrochloride
Naltrexone impurity C N-(3-butenyl)-noroxymorphone
Nandrolone decanoate
Nandrolone decanoate for peak identification
Nandrolone decanoate for system suitability
Naphazoline hydrochloride
Naphazoline nitrate
Naphazoline impurity A N-(2-aminoethyl)-2-(naphthalen-1-yl)acetamide (Naphthylacetylethylenediamine)
Naproxen
Naproxen (racemic)
Naproxen impurity L 1-(6-Methoxynaphthalen-2-yl)ethanone (Acetylnerolin)
Naringin
Nateglinide
Nateglinide impurity A trans-4-(1-methylethyl)cyclohexanecarboxylic acid
Nateglinide impurity B N-[[trans-4-(1-methylethyl)cyclohexyl]carbonyl]-Lphenylalanine (L-phenylalanine isomer)
Nateglinide impurity C N-[[cis-4-(1-methylethyl)cyclohexyl]carbonyl]-D-phenylalanine (cis-isomer)
Neamine
Neohesperidin dihydrochalcone
Neohesperidin dihydrochalcone impurity B 7-[[2-O-(6-deoxy-α-L-mannopyranosyl)-ß-D-glucopyranosyl]oxy]-5-hydroxy-2- (3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-one (neodiosmin)
Neomycin sulfate
Neomycin sulphate for microbiological assay
Neostigmine bromide
Neostigmine metilsulfate
Netilmicin sulphate
Nevirapine (anhydrous)
Nevirapine hemihydrate
Nevirapine for peak identification
Newcastle Disease Vaccine (inacativated) BRP
Nicergoline - Reference Spectrum
Nicergoline
Nicergoline for peak identification
Nicergoline for system suitability
Nicergoline impurity A [(6aR,9R,10aS)-10a-methoxy-4,7-dimethyl- 4,6,6a,7,8,9,10,10a-octahydroindol [4,3-fg]quinolin-9-yl]methyl 5-chloropyridine-3-carboxylate
Nicergoline impurity D 5-bromopyridine-3-carboxylic acid
Niclosamide (anhydrous)
Nicotinamide
Nicotine - Reference Spectrum
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
10 mg
EPN0050000
EPN0075000
EPY0000695
EPY0000400
EPY0000410
EPY0000542
EPY0000547
EPY0000548
EPN0080000
EPN0100000
EPN0200000
EPN0250000
EPY0000399
EPY0000631
New EPY0001378
New EPY0001437
New EPY0001440
New EPY0001441
100 mg
100 mg
10 mg
50 mg
15 mg
5 mg
10 mg
10 mg
50 mg
10 mg
10 mg
100 mg
10 mg
10 mg
20 mg
200 mg
10 mg
15 mg
New EPY0001442
EPN0300000
EPN0399000
EPN0399004
10 mg
0.5 mg
125 mg
10 mg
EPN0400000
EPN0401000
EPN0500000
EPN0550000
EPN0559000
EPY0000520
New EPY0001499
EPY0000521
EPY0000388
EPY0000287
EPY0001373
EPY0001362
EPY0001352
EPY0000283
50 mg
25 mg
50 mg
50 mg
2x25 mg
30 mg
15 mg
0.058 mg
4 uc
unit
50 mg
1 mg
10 mg
10 mg
EPY0001356
EPN0560000
EPN0600000
EPN0590000
Edition 2012/2013
20 mg
50 mg
50 mg
unit
287
Table of content
European Pharmacopoeia
Code Product Unit
EPN0590200
New EPY0001425
EPY0001023
EPN0700000
EPY0001268
EPN0750000
EPN0750010
EPN0750015
EPY0000824
EPY0000825
EPY0000826
EPY0000827
EPY0000836
EPN0800000
EPY0000829
EPY0000894
EPN0845000
EPN0845008
EPY0001237
EPN0850000
EPN0850010
Nicotine ditartrate
Nicotine ditartrate dihydrate
Nicotine for system suitability
Nicotinic acid
Nicotinic acid impurity mixture
Nifedipine
Nifedipine impurity A Dimethyl 2,6-dimethyl-4-(2-nitrophenyl) pyridine-3,5-dicarboxylate
Nifedipine impurity B Dimethyl 2,6-dimethyl-4-(2-nitrosophenyl) pyridine-3,5-dicarboxylate
Niflumic acid
Niflumic acid impurity A 2-chloropyridine-3-carboxylic acid
Niflumic acid impurity B 2-hydroxy-N-(3-(trifluoromethyl)phenyl)pyridine-3-carboxamide
Niflumic acid impurity E 6-((3-(trifluoromethyl)phenyl)amino)pyridine-3-carboxylic acid
Nifuroxazide
Nikethamide
Nilutamide
Nilutamide impurity B 4-nitro-3-(trifluoromethyl)aniline
Nimesulide
Nimesulide impurity D 4-nitro-2-phenoxyaniline
Nimesulide for peak identification
Nimodipine
Nimodipine impurity A 2-methoxyethyl 1-methylethyl 2,6-dimethyl-4-(3-nitrophenyl) pyridine-3,5-dicarboxylate
Nitrazepam Controlled Substance
Nitrazepam impurity A 3-amino-6-nitro-4-phenylquinol-2-one
Nitrendipine
Nitrendipine for peak identification
Nitrendipine impurity A ethyl methyl-2,6-dimethyl-4-(3-nitrophenyl) pyridine-3,5-dicarboxylate; (nitrophenylpyridine analogue)
Nitric oxide - Reference Spectrum
Nitrofural
Nitrofural for peak identification
Nitrosotriaminopyrimidine
Nizatidine
Nizatidine for system suitability
Nizatidine impurity F (EZ)N1,N1-[thiazole-2,4-diylbis(methylenesulphanediylethylene)] bis(N’-methyl-2-nitroethene-1,1-diamine)
Nomegestrol acetate
Nomegestrol acetate impurity A 6-alpha-methyl-3,20-dioxo-19-norpregn-4-en-17-yl acetate
1-nonadecanol
Nonivamide
Nonoxinol 9
Noradrenaline tartrate
120 mg
15 mg
1 mg
100 mg
0.12 mg
50 mg
20 mg
20 mg
10 mg
10 mg
10 mg
15 mg
10 mg
1 mL
110 mg
5 mg
100 mg
0.004 mg
10 mg
50 mg
1 mL
EPN0900000
EPN0900010
EPN0905000
New EPY0001456
EPN0905005
100 mg
25 mg
60 mg
10 mg
30 mg
EPN0930000
EPN0950000
EPY0001377
EPN1000000
EPN1090000
New EPY0001278
EPN1090060
unit
100 mg
0.11 mg
50 mg
250 mg
10 mg
10 mg
EPN1080000
EPN1080005
EPY0001314
EPY0000670
EPY0000755
EPN1100000
100 mg
50 mg
400 mg
10 mg
10 mg
200 mg
288 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000681 Noradrenaline impurity D 4[(1R)-2-amino-1-methoxyethyl]benzene-1,2-diol (Noradrenaline methyl ether)
Noradrenaline impurity E 2-chloro-1-(3,4-dihydroxyphenyl)ethanone
Noradrenaline impurity F N-benzyl-1-phenylmethanamine
Norcyclobenzaprine
Nordazepam Controlled Substance Dipotassium clorazepate impurity B
Norethisterone
Norethisterone acetate
Norethistherone for system suitability
Norfloxacin
Norfloxacin for peak identification
Norfloxacin impurity A 7-chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
Norfloxacin for system suitability
Norgestimate
Norgestimate for system suitability
Norgestrel
Norpseudoephedrine hydrochloride Controlled Substance
Nortriptyline for system suitability
Nortriptyline hydrochloride
Noscapine
Nystatin
Octoxinol 10
Octyl gallate
Octyldodecanol
Ofloxacin
Ofloxacin impurity A (RS)-9,10-difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido [1,2,3-de][1,4]benzoxazine-6-carboxylic acid (FPA)
Ofloxacin impurity E (RS)-9-fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido [1,2,3-de] [1,4]benzoxazine-6-carboxylic acid
Olanzapine
Olanzapine for system sitability
Olanzapine impurity A 5-methyl-2-[(2-nitrophenyl)amino]thiophene-3-carbonitrile
Oleic acid
Oleuropein
Olmesartan medoxomil
Olmesartan medoxomil for system suitability
Olsalazine sodium
Olsalazine sodium for performance test
Omeprazole
Omeprazole magnesium
Omeprazole for peak identification
Omeprazole impurity D Omeprazole sulphone
Ondansetron hydrochloride dihydrate
Ondansetron for LC system suitability
Ondansetron for TLC system suitability
15 mg
EPY0000682
EPY0000686
EPN1130000
EPN1140000
EPN1200000
EPN1225000
EPY0000522
EPN1230000
EPY0001301
EPN1230010
EPY0001015
EPY0000724
EPY0000725
EPN1250000
EPN1279000
EPY0001296
EPN1280000
EPN1300000
EPN1400000
EPO0100900
EPY0000368
EPO0101000
EPO0120000
EPO0120010
10 mg
10 mg
25 mg
50 mg
100 mg
100 mg
10 mg
50 mg
10 mg
20 mg
8 mg
10 mg
5 mg
30 mg
50 mg
20 mg
10 mg
100 mg
100 mg
300 mg
30 mg
400 mg
50 mg
20 mg
EPO0120050 20 mg
New EPY0001370
New EPY0001380
New EPY0001392
New EPY0001479
EPY0000805
New EPY0001405
New EPY0001424
EPO0146000
EPO0146010
EPO0150000
EPY0001043
EPY0001042
EPO0151000
EPY0000218
EPY0000197
EPY0000196
200 mg
10 mg
5 mg
2000 mg
20 mg
100 mg
10 mg
60 mg
60 mg
50 mg
10 mg
10 mg
10 mg
200 mg
10 mg
30 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 289
Table of content
European Pharmacopoeia
Code Product Unit
EPY0001345 Ondansetron impurity A (3RS)-3-[(dimethylamino)methyl]-9-methyl-1,2,3,9- tetrahydro-4H-carbazol-4-one
Ondansetron impurity D 9-methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one
Ondansetron impurity E Imidazole
Ondansetron impurity F
Ondansetron impurity G (3RS)-3-[(1H-imidazol-1-yl)methyl]-9-methyl-1,2,3,9-tetrahydro- 4H-carbazol-4-one (C-demethylondansetron)
Orbifloxacin
Orbifloxacin impurity mixture
Orciprenaline sulfate
Orciprenaline for system suitability
Orphenadrine citrate
Orphenadrine hydrochloride
Orphenadrine for peak identification
Orphenadrine impurity E (RS)-N,N-dimethyl-2-[(3-methylphenyl)phenylmethoxy]ethanamine (meta-methylbenzyl isomer)
Oseltamivir phosphate impurity B free
Oseltamivir impurity A (3R,4R,5S)-5-acetamido-4-amino-3-(1-ethylpropoxy)cyclohex-1-ene-1-carboxylic acid
Oseltamivir impurity B ethyl (1R,2R,3S,4R,5S)-4-acetamido-5-amino-2-azido-3- (1-ethylpropoxy)cyclohexanecarboxylate
Oseltamivir impurity C (3R,4R,5S)-4-acetamido-5-amino-3-(1-ethylpropoxy)cyclohex-1-ene-1-carboxylic acid
Oseltamivir impurity H tributylphosphane oxide
Osthole
Ouabain
Oxacillin sodium monohydrate
Oxacillin for peak identification
Oxaliplatin
Oxaliplatin impurity C (OC-6-33)-[(1R,2R)-cyclohexane-1,2-diamine-kN,kN'][ethanedioato(2-)- kO¹,kO²]dihydroxyplatinum
Oxaliplatin impurity D (SP-4-2)-[(1S,2S)-cyclohexane-1,2-diamine-kN,kN'][ethanedioato(2-)- kO¹,kO² ]platinum (S,S-enantiomer of oxaliplatin)
Oxazepam Controlled Substance
Oxazepam for peak identification
Oxeladin hydrogen citrate
Oxeladin impurity C 2-(diethylamino)ethyl 2-ethyl-2-phenylbutanoate
Oxeladin impurity D 2-(2-diethylaminoethoxy)ethyl 2-phenyl-butyrate dihydrogen citrate
Oxfendazole for veterinary use
Oxfendazole impurity B methyl[5-(phenylsulphonyl)-1H-benzimidazole-2-yl]carbamate
Oxfendazole with impurity D
Oxitropium bromide Oxitropium bromide impurity B (1R,2R,4S,5S,7s)-7-[[(2S)-3-hydroxy-2-phenylpropanoyl)oxy]-9,9-dimethyl-3-oxa-9- azoniatricyclo[3.3.1.02,4]nonane (methylhyoscine)
10 mg
EPY0000195
EPY0001326
EPY0001320
EPY0001346
10 mg
10 mg
10 mg
10 mg
EPY0001125
EPY0001147
EPO0180000
EPY0000895
EPY0000101
EPY0000100
EPY0001181
EPY0000102
200 mg
0.0008 mg
100 mg
5 mg
100 mg
100 mg
0.42 mg
30 mg
EPY0001337
EPY0001338
EPY0001339
300 mg
10 mg
10 mg
EPY0001340
EPY0001341
EPY0001207
EPO0200000
EPY0000638
EPY0000560
EPY0000271
EPY0000273
10 mg
30 mg
20 mg
150 mg
110 mg
10 mg
250 mg
25 mg
EPY0000274 10 mg
EPO0225000
EPY0000543
EPY0000350
EPY0000404
EPY0000390
EPO0225800
EPY0000224
EPY0000225
EPY0000709
EPY0000715
50 mg
0.008 mg
50 mg
10 mg
20 mg
50 mg
10 mg
10 mg
50 mg
15 mg
290 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000713 Oxitropium bromide impurity D (1R,2R,4S,5S,7s,9r)-9-ethyl-9-methyl-7-[(2-phenylprop-2-enoyl)oxy]-3-oxa-9- azoniatricyclo[3.3.1.02,4]nonane (apo-N-ethylhyoscine)
Oxolinic acid
Oxolinic acid impurity A 8-hydroxy-1,3-dioxolo[4,5-g]quinoline-7-carboxylic acid
Oxolinic acid impurity B ethyl 5-ethyl-8-oxo-5,8-dihydro-1,3-dioxolo[4,5-g]quinoline-7-carboxylate
Oxprenolol hydrochloride
Oxibendazole
Oxybuprocaine hydrochloride
Oxybutynin hydrochloride
Oxybutynin impurity A 4-(diethylamino)but-2-ynyl(RS)-2-(cyclohex-3-enyl)-2-cyclohexyl-2-hydroxyacetate
Oxycodone hydrochloride Controlled Substance
Oxycodone impurity D 7,8-didehydro-4,5 alpha-epoxy-14-hydroxy-3-methoxy-17- methylmorphinan-6-one (14-hydroxycodeinone)
Oxymetazoline hydrochloride
Oxymetazoline impurity A N-(2-aminoethyl)-2-[4-(1,1-dimethylethyl)-3-hydroxy-2,6-dimethylphenyl]acetamide
Oxytetracycline
Oxytetracycline hydrochloride
Oxytocin
Oxytocin/Desmopressin validation mixture about 0.1 mg oxytocin + 0.1 mg desmopressin per vial
Paclitaxel
Paclitaxel impurity C N-debenzoyl-N-hexanoylpaclitaxel
Paclitaxel natural for peak identification
Paclitaxel semi-synthetic for peak identification
Paclitaxel semi-synthetic for system suitability
Palmitic acid
Pamidronate disodium pentahydrate
Pancrease powder (amylse and lipase) BRP
Pancreas powder (protease) BRP
Pancuronium bromide Vecuronium impurity B
Pancuronium bromide for system suitability
Pantoprazole sodium sesquihydrate
Pantoprazole for system suitability
Papaverine hydrochloride
Paracetamol
Paraffin (hard)
Paraffin (liquid) - Reference Spectrum
Paraffin (White soft)
Paraffin (Yellow soft)
Parnaparin sodium
Paroxetine hydrochloride (anhydrous)
Paroxetine hydrochloride hemihydrate
Paroxetine impurity A (3S,4R)-3-[[1,3-benzodioxol-5-yloxy]methyl]-4-phenylpiperidine (desfluoroparoxetine)
Paroxetine hydrochloride (anhydrous) impurity C (3S,4R)-3-[(1,3-benzodioxol-5-yloxy)methyl]-1-benzyl-4-(4-fluorophenyl)piperidine (N-benzylparoxetine)
10 mg
EPO0240000
EPO0240005
EPO0240010
EPO0250000
EPO0260000
EPO0270000
EPO0288000
EPO0288005
EPY0000492
EPY0000453
50 mg
20 mg
20 mg
50 mg
100 mg
150 mg
150 mg
10 mg
100 mg
50 mg
EPO0290000
EPY0001044
EPO0400000
EPO0500000
EPO0700000
EPO0770000
EPY0000698
EPY0000699
EPY0000700
EPY0000719
EPY0000739
EPP0090000
EPY0000524
EPP0100000
EPP0200000
EPP0250000
EPY0000577
EPY0000835
EPY0001001
EPP0270000
EPP0300000
EPY0000780
EPY0000058
EPY0000913
EPY0000912
EPP0305000
EPY0000578
EPY0000281
EPY0000233
EPY0000579
80 mg
10 mg
100 mg
20 mg
1 mg
0.2 mg
40 mg
5 mg
10 mg
10 mg
1 mg
100 mg
10 mg
2000 mg
2000 mg
20 mg
20 mg
20 mg
0.5055 mg
25 mg
50 mg
10 mg
unit
10 mg
10 mg
250 mg
100 mg
200 mg
15 mg
10 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 291
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000256 Paroxetine impurity D (3R,4S)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine ((+)-trans- paroxetine)
Paroxetine impurity E (3RS,4RS)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4fluorophenyl)piperidine (cis-paroxetine)
Paroxetine hydrochloride (anhydrous) impurity H [(3S,4R)-1-benzyl-4-(4-fluorophenyl)piperidin-3-yl]methanol
Paroxetine for system suitability
Pefloxacin mesilate dihydrate
Pefloxacin impurity B 1-ethyl-6-chloro-7-(4-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (chlorinated homologue of pefloxacin)
Pefloxacin impurity C 1-ethyl-6-fluoro-5-(4-methylpiperazin-1yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (isopefloxacin)
Penbutolol sulfate
Penbutolol impurity A (2S)-1-[2-(cyclopent-1-enyl)phenoxy]-3-[(1,1-dimethylethyl)amino]propan-2-ol
Penicillamine
Penicillamine disulphide 3,3-(disulphanediyl)bis[(2)-2-amino-3-methylbutanoic]acid
Pentamidine diisetionate
Pentazocine - Reference Spectrum
Pentazocine hydrochloride - Reference Spectrum
Pentazocine lactate - Reference Spectrum
Pentetate sodium calcium
Pentobarbital Controlled Substance
Pentoxifylline
Pentoxyverine hydrogen citrate - Reference Spectrum
Pentoxyverine impurity A 1-phenylcyclopentanecarboxylic acid
Pentoxyverine impurity B 2-(diethylamino)ethyl-1-phenylcyclopentanecarboxylate (caramiphen)
Pepsin powder
Pergolide mesilate
Perindopril impurity A (2S,3aS,7aS)-octahydro-1Hindole-2-carboxylic acid
Perindopril for stereochemical purity
Perindopril tert-butylamine
Perindopril for peak identification
Perphenazine
Perphenazine for system suitability
Pertussis toxin BRP
Pethidine hydrochloride - Reference Spectrum Pethidine impurity A 1-methyl-4-phenylpiperidine (MPP)
Phenazone
Phenazone impurity A 5-methyl-2-phenyl-2,4-dihydro-3-pyrazol-3-one
Pheniramine impurity A 2-Benzylpyridine
Pheniramine maleate
Phenobarbital Controlled Substance
Phenobarbital impurity A (5RS)-5-ethyl-2,6-diimino-5-phenyltetrahydropyrimidin-4(1H)-one
Phenobarbital impurity B (5RS)-5-ethyl-6-imino-5-phenyldihydropyrimidine-2,4(1H,3H)-dione
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
5 mg
EPY0000580
EPY0000581
EPY0000630
EPP0309000
EPP0309020
5 mg
10 mg
5 mg
200 mg
10 mg
EPP0309030 0.01 mg
EPP0307000
EPP0307005
EPP0310000
EPP0320000
EPP0405000
EPP0405500
EPP0405510
EPY0000417
EPY0001051
EPP0500000
EPP0510000
EPY0000076
EPY0000098
EPY0000099
EPP0525000
EPY0000010
EPY0000237
EPY0000207
EPY0000238
EPY0000771
EPP0550000
EPY0001045
EPY0000021
EPP0600000
EPP0600002
EPP0800000
EPY0001138
New EPY0001428
EPP0850000
EPP0900000
EPY0001350
EPY0001351
100 mg
20 mg
100 mg
100 mg
30 mg
unit
unit
unit
100 mg
500 mg
100 mg
unit
10 mg
10 mg
2000 mg
150 mg
10 mg
40 mg
40 mg
5 mg
100 mg
5 mg
2x0.05 mg
unit
20 mg
20 mg
20 mg
20 mg
250 mg
200 mg
15 mg
15 mg
292 Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPP0950000
EPP1000000
EPP1100000
EPP1109000
EPY0001127
EPY0001251
EPP1150000
EPP1200000
EPY0000147
EPP1240000
EPP1250000
EPY0000683
EPY0000229
EPP1255100
EPP1260000
EPP1290000
EPY0001167
EPP1300000
EPY0000493
EPY0000761
EPY0000798
EPY0000766
EPP1500000
EPP1600000
EPP1605000
EPP1609000
EPP1609010
EPP1645000
EPP1645005
EPY0000124
EPY0000123
EPP1650000
EPP1700000
EPY0000106
EPY0000525
EPY0000401
EPP1750000
EPP1800000
New EPY0001519
New EPY0001520
New EPY0001476
EPY0000061
EPP1890000
EPP1900000
EPP2000000
EPP2100000
EPY0000288
EPY0000038
Phenoxyethanol
Phenoxymethylpenicillin
Phenoxymethylpenicillin potassium
Phentolamine mesilate - Reference Spectrum
Phentolamine mesilate
Phentolamine mesilate for system suitability
Phenylalanine
Phenylbutazone
Phenylbutazone impurity B (4-butyl-4-hydroxy-1,2-diphenyl-3,5)pyrazolidinedione
Phenylephrine
Phenylephrine hydrochloride
Phenylephrine hydrochloride for peak identification
Phenylmercuric acetate - Reference Spectrum
Phenylmercuric borate - Reference Spectrum
Phenylpropanolamine hydrochloride (Norephedrin hydrochloride) Drug Precursor
Phenytoin
Phenytoin for system suitability
Phenytoin sodium
Phloroglucinol (anhydrous)
Pholcodine Controlled Substance
Pholcodine for peak identification Controlled Substance Phthalic acid benzene-1,2-dicarboxylic acid
Phthalylsulfathiazole
Physostigmine salicylate
Physostigmine sulfate
Phytomenadione
trans-Epoxyphytomenadione
Picotamide monohydrate
Picotamide impurity A 4-methoxybenzene-1,3-dicarboxylic acid
Pidolate impurity B (2S)-2-[[[(2S)-5-oxopyrrolidin-2-yl]carbonyl]amino]pentanedioic acid
Pidolic acid
Pilocarpine hydrochloride
Pilocarpine nitrate
Pilocarpine nitrate for system suitability
Pimobendan
Pimobendan for system suitability
Pimozide
Pindolol
Pioglitazone for system suitability
Pioglitazone hydrochloride
Pipemidic acid trihydrate
Pipemidic acid trihydrate - Reference Spectrum
Piperacillin
Piperazine adipate
Piperazine citrate
Piperazine hydrate
Piracetam
Pirenzepine dihydrochloride monohydrate
2 mL
250 mg
250 mg
unit
10 mg
10 mg
60 mg
100 mg
20 mg
60 mg
50 mg
2 mg
unit
unit
50 mg
100 mg
20 mg
250 mg
210 mg
10 mg
10 mg
20 mg
100 mg
100 mg
100 mg
150 mg
10 mg
125 mg
25 mg
60 mg
125 mg
50 mg
50 mg
20 mg
10 mg
0.1 mg
150 mg
100 mg
15 mg
120 mg
15 mg
unit
100 mg
250 mg
250 mg
250 mg
120 mg
250 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 293
Table of content
European Pharmacopoeia
Code Product Unit
EPP2120000
New EPY0001458
EPP2120002
EPP2130000
EPP2150000
EPP2152000
EPP2152015
Piretanide
Piretanide for system suitability
Piretanide impurity A 4-phenoxy-3(1H-pyrrol-1-yl)-5-sulphamoylbenzoic acid
Piroxicam
Pivampicillin
Pivmecillinam hydrochloride
Pivmecillinam impurity C methylene 2,2-dimethylpropanoate (2RS,4S)-2-[[[(hexahydo-1H-azepin-1-yl) methylene]amino]methyl]-5,5-dimethylthiazolidin-4-carboxylate
Plastic additive 01 (2RS)-2-ethylhexyl)benzene-1,2-dicarboxylate
Plastic additive 03 N,N'-ethylenedialcanamide
Plastic additive 04 Epoxidised soya oil
Plastic additive 05 Epoxidised linseed oil
Plastic additive 08 Ethylene bis [3,3-bis[3-(1,1-dimethylethyl)-4-hydroxyphenyl]butanoate]
Plastic additive 09 pentaerythrityl tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
Plastic additive 10 4,4',4''-(2,4,6-trimethylbenzene-1,3,5-triyltrismethylene)-trio[2,6-bis(1,1-dimethylethyl)phenol]
Plastic additive 11 Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate
Plastic additive 12 Tris(2,4-di-1,1-dimethylethylphenyl)phosphite R
Plastic additive 13 1,3,5-tris(3,5-di-1,1-dimethylethyl-4-hydroxybenzyl)-1H,3H,5H-1,3,5-triazine-2,4,6-trione
Plastic additive 14 2,2'-Di(octadecycloxy)5,5'-spirobi(1,3,2,-dioxaphosphorinane) R
Plastic additive 15 Dioctadecyl disulphide
Plastic additive 16 Didodecyl 3,3'-thiodipropionate R
Plastic additive 17 Dioctadecyl 3,3'-thiodipropionate R
Plastic additive 18
Plastic additive 20 Oleamide R
Plastic additive 21 Erucamide R
Plastic additive 22 Copolymer of dimethyl butanedioate and 1-(2-hydroxyethyl)-2,2,6,6-tetramethylpiperidin-4-ol Synonyms: copolymer of dimethyl succinate and (4-hydroxy-2,2,6,6-tetramethylpiperidin-1- yl)ethanol
Plastic additive 23 di(isooctyl)2,2'-[(dioctylstannylene)bis(thio)]diacetate containing about 27% of (tri(isooctyl)2,2',2''-[monooctylstannylidyne)tris(thio)]triacetate Tin-content of 15.4%
Poliomyelitis vaccine (inactivated) BRP
Poliomyelitis vaccine (oral) BRP
Poloxamer 124
Poloxamer 188
Poloxamer 237
Poloxamer 338
Poloxamer 407
Polyacrylate - Reference Spectrum
Polymyxin B sulfate
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
100 mg
10 mg
20 mg
100 mg
50 mg
100 mg
10 mg
EPP2155001
EPP2155003
EPE0800000
EPP2155005
EPP2155008
EPP2155009
EPP2155010
EPP2155011
EPP2155012
EPP2155013
EPP2155014
EPP2155015
EPP2155016
EPP2155017
EPP2155018
EPO0140000
EPE1260000
EPP2155022
2 mL
100 mg
500 mg
500 mg
500 mg
250 mg
250 mg
500 mg
250 mg
250 mg
250 mg
500 mg
250 mg
250 mg
100 mg
100 mg
100 mg
100 mg
EPP2155023 200 mg
EPP2160000
EPP2161000
EPP2163920
EPP2164009
EPP2164020
EPP2164021
EPP2164030
EPP2170000
EPP2400000
294
5x0.5 mL
5x1 mL
30 mg
100 mg
100 mg
100 mg
100 mg
unit
25 mg
Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000355
EPY0000289
EPY0000290
EPY0000291
EPY0000007
EPY0000792
EPP2600000
EPP2649610
EPY0001168
EPY0000315
EPP2650000
EPY0001275
EPP2660000
EPY0000466
EPY0001266
EPY0001187
EPY0001267
EPY0000215
EPY0000223
Polymyxin B sulfate for microbiological assay
Polysorbate 20 - Reference Spectrum
Polysorbate 40 - Reference Spectrum
Polysorbate 60 - Reference Spectrum
Polysorbate 80 - Reference Spectrum
Poly(vinyl acetate) dispersion 30%
Poly(vinyl chloride)
Potassium clavulanate - Reference Spectrum
Potassium clavulanate impurity G
Potassium hydrogen aspartate hemihydrate
Potassium sorbate
Potassium sucrose octasulfate
Povidone
Povidone (iodinated)
Pramipexole dihydrochloride monohydrate
Pramipexole for system suitability
Pramipexole impurity D (6R)-6-N-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine
Pravastatin sodium - Reference Spectrum
Pravastatin impurity A (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6R,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)- 2-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoic acid (6'-epipravastatin)
Pravastatin 1,1,3,3-tetramethylbutylamine
Prazepam Controlled Substance
Praziquantel
Praziquantel impurity A (11bRS)-2-benzoyl-1,2,3,6,7,11b-hexahydro-4H-pyrazino[2,1-a]isoquinolin-4-one
Prazosin hydrochloride
Prednicarbate
Prednicarbate for system suitability
Prednicarbate impurity F 1,2-dihydroprednicarbate
Prednisolone
Prednisolone for peak identification
Prednisolone for system suitability
Prednisolone acetate
Prednisolone acetate for peak identification
Prednisolone hexanoate
Prednisolone pivalate
Prednisolone sodium phosphate
Prednisone
Pregnenolone isobutyrate
Prekallikrein activator in albumin BRP
Prilocaine
Prilocaine hydrochloride
Prilocaine impurity B 2-methylbenzenamine hydrochloride
Prilocaine impurity E (RS)-N-(methylphenyl)-2-(propylamino)propanamide
Primaquine diphosphate
Primidone
Primidone for peak identification
25 mg
unit
unit
unit
unit
1500 mg
100 mg
unit
5 mg
50 mg
100 mg
100 mg
50 mg
10 mg
5 mg
15 mg
5 mg
unit
0.1 mg
EPY0000204
EPP2669000
EPP2670000
EPP2675000
EPP2680000
EPP2698000
New EPY0001443
EPP2698060
EPP2700000
EPY0001359
EPY0001355
EPP2800000
EPY0000582
EPP2804000
EPP2805000
EPP2810000
EPP2900000
EPP2920000
EPY0000263
EPP2939000
EPP2939060
New EPY0001408
EPP2939025
EPP2940000
EPP2950000
EPY0000369
30 mg
50 mg
150 mg
10 mg
50 mg
100 mg
10 mg
10 mg
150 mg
10 mg
10 mg
120 mg
10 mg
10 mg
100 mg
100 mg
100 mg
150 mg
3x1 mL
150 mg
100 mg
80 mg
25 mg
500 mg
150 mg
5 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 295
Table of content
European Pharmacopoeia
Code Product Unit
EPP3000000
EPP3050000
EPP3090000
EPP3100000
EPP3200000
EPP3300000
EPY0000148
EPY0000179
EPY0000181
EPY0000182
EPP3350000
EPP3390000
EPP3400000
EPY0000769
EPY0000797
EPP3490000
EPY0000455
EPY0000456
Probenecid
Procainamide hydrochloride
Procaine benzylpenicillin
Procaine hydrochloride
Prochlorperazine maleate
Progesterone
Progesterone impurity C (20R)-20-hydroxypregn-4-en-3-one
Proguanil hydrochloride - Reference Spectrum
Proguanil impurity C 1,5-bis(4-chlorophenyl)biguanide
Proguanil impurity D 1,5-bis(1-methylethyl)biguanide
Proline
Promazine hydrochloride
Promethazine hydrochloride
Promethazine impurity D (2RS)-N,N-dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine S-oxide
Promethazine for peak identification
Propacetamol hydrochloride - Reference Spectrum
Propafenone hydrochloride
Propafenone impurity B 2E)-1-[2-[(2RS)-2-hydroxy-3-(propylamino)propoxy] phenyl]-3-phenylprop-2-en-1-one
Propanol - Reference Spectrum
Propofol
Propofol for peak identification
Propofol impurity J 2,6-bis (1-methylethyl)-1,4-benzoquinone
Propranolol hydrochloride
Propranolol hydrochloride for performance test
Propylene glycol dilaurate
Propylene glycol monolaurate
Propyl gallate
Propyl parahydroxybenzoate
Propylthiouracil
Propyphenazone
Protirelin
D-His Protirelin
Proxyphylline
Pseudoephedrine hydrochloride Drug Precursor
Pseudoisoeugenyl 2-methylbutyrate for peak identification
Purpureaglycoside A
Purpureaglycoside B
Pyrantel embonate
Pyrantel impurity A 1-methyl-2-[(Z)-2-(thiophen-2-yl)ethenyl]-1,4,5,6-tetrahydropyrimidine
Pyrazinamide
Pyridostigmine bromide
Pyridostigmine impurity A pyridin-3-yl-dimethylcarbamate
Pyridostigmine bromide impurity B 3-hydroxy-1-methylpyridinium
Pyridoxine hydrochloride
100 mg
100 mg
250 mg
100 mg
100 mg
50 mg
10 mg
unit
10 mg
10 mg
60 mg
100 mg
50 mg
10 mg
10 mg
unit
10 mg
10 mg
EPY0000278
EPY0000016
EPY0000017
EPY0000018
EPP3500000
EPP3600000
EPY0000318
EPY0000319
EPP3640000
EPP3650000
EPP3700000
EPP3750000
EPP3760000
EPP3760020
EPP3800000
EPP3850000
EPY0000387
EPP3900000
EPP4000000
EPY0000402
EPY0000403
EPP4050000
EPP4099900
EPP4099910
New EPY0001486
EPP4100000
unit
290 mg
0.1 mL
20 mg
30 mg
20 mg
100 mg
100 mg
50 mg
150 mg
100 mg
200 mg
2x5.03 mg
0.1 mg
100 mg
50 mg
100 mg
25 mg
25 mg
10 mg
20 mg
30 mg
50 mg
20 mg
10 mg
100 mg
296 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0001226
EPP4200000
EPY0000659
EPY0001009
EPQ0100000
EPQ0200000
EPR0100000
EPY0000896
EPY0000897
EPY0000898
EPY0000902
EPY0001134
EPY0001135
EPR0145000
EPR0145005
Pyridoxine impurity A 6-methyl-1,3-dihydrofuro[3,4-c]pyridin-7-ol
Pyrimethamine
Pyrrolidone
Quercetin dihydrate
Quinidine sulfate
Quinine sulfate
Rabies vaccine (inactivated) for veterinary use BRP
Racecadotril
Racecadotril impurity A Ethanethioic acid
Racecadotril impurity G benzyl[[(2RS)-2-benzyl-3-sulfanylpropanoyl]amino]acetate
Racecadotril for peak identification
Raloxifene hydrochloride
Raloxifene hydrochloride for peak identification
Ramipril
Ramipril impurity A (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-(methoxycarbonyl)-3-phenylpropyl]amino] propanoly]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (ramipril methylester)
Ramipril impurity B (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-[(methylethoxy)carbonyl]-3-phenylpropyl] amino] propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (ramipril isopropyl ester)
Ramipril impurity C (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-(ethoxycarbonyl)-3-cyclohexylpropyl]amino] propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (hexahydroramipril)
Ramipril impurity D ethyl(2S)-2-[(3S,5aS,8aS,9aS)-3-methyl-1,4-dioxodecahydro -1H-cyclopenta[e]pyrrolo[1,2a]pyrazin-2-yl]-4-phenylbutanoate (ramipril diketopiperazine)
Ranitidine hydrochloride
Ranitidine impurity J 1,1'-N-[methylenebis(sulphanediylethylene)]bis (N'-methyl-2-nitroethene-1,1-diamine)
Ranitidine for system suitability
Repaglinide
Repaglinide for system suitability
Repaglinide impurity E 2-ethoxy-4-[2-[[(1R)-3-methyl-1-[2-(piperidin-1-yl)phenyl]butyl]amino]- 2-oxoethyl]benzoic acid
Reserpine
Residual solvents solution class I
Resorcinol
Retinol acetate
Retinol ester
Reviparin sodium
Ribavirin
Riboflavin (Vitamine B2)
Riboflavin for peak identification
Riboflavine sodium phosphate
Ribonucleic acid
Rifabutin
Rifabutin impurity A 1-(2-methylpropyl)piperidin-4-one
Rifampicin
Rifampicin quinone
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
5 mg
250 mg
20 mg
20 mg
300 mg
300 mg
3x86 mg
110 mg
1 mL
10 mg
5 mg
110 mg
10 mg
20 mg
10 mg
EPR0145010 10 mg
EPR0145015 10 mg
EPR0145020 10 mg
EPR0150000
EPY0000416
100 mg
0.00025 mg
EPY0000411
EPY0000457
EPY0000458
EPY0000459
EPR0200000
EPR0250000
EPY0000767
EPR0300000
EPR0290000
EPR0500500
EPY0000377
EPR0600000
EPY0000757
EPR0630000
EPY0000662
EPY0000149
EPY0000184
EPR0700000
EPR0800000
Edition 2012/2013
20 mg
20 mg
6 mg
10 mg
100 mg
1.4 mL
20 mg
1000 mg
100 mg
250 mg
2x150 mg
100 mg
0.12 mg
250 mg
100 mg
150 mg
20 mg
100 mg
100 mg
297
Table of content
European Pharmacopoeia
Code Product Unit
EPR0900000
EPR0950000
EPR1000000
EPY0001074
EPY0001075
EPY0000250
EPY0000187
EPR1000600
EPY0000370
EPY0001276
Rifamycin B
Rifamycin S
Rifamycin sodium
Rifaximin
Rifaximin for system suitability
Rilmenidine dihydrogenophosphate - Reference Spectrum
Rilmenidine for system suitability
Risperidone
Risperidone for system suitability
Risperidone impurity K 3-[2-[4-(1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4Hpyrido[1,2- a]pyrimidin-4-one (desfluoro risperidone)
Ritonavir
Ritonavir for peak identification
Rivastigmine for system suitability
Rizatriptan benzoate
Rizatriptan for system suitability
RK 13 cells cell lines (kidney,rabbit) titration of live measles, mumps and rubella vaccines
Rocuronium bromide - Reference Spectrum
Rocuronium for peak identification
Ropivacaine hydrochloride monohydrate
Ropivacaine impurity G (+)-(2R)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide ((R)-ropivacaine)
Rosmarinic acid
Roxithromycin
Roxithromycin for system suitability
Rubella vaccine (live) BRP
Ruscogenins
Rutoside trihydrate
Saccharin
Saccharin Sodium
Salbutamol
Salbutamol impurity B (1RS)-2-[(1,1-dimethylethyl)amino]-1-(4-hydroxyphenyl)ethanol
Salbutamol impurity D 5-[(1RS)-2-[(1,1-dimethylethyl)amino]-1-hydroxyethyl]-2- hydroxybenzaldehyde
Salbutamol impurity F 1,1'[oxybis[methylene(4-hydroxy-1,3-phenylene)]]bis [2-[(1,1-dimethylethyl)amino]ethanol]
Salbutamol impurity G 2-[benzyl(1,1-dimethylethyl)amino]-1-[4-hydroxy-3-hydroxymethyl) phenyl]ethanone
Salbutamol impurity I (1RS)-2-[(1,1-dimethylethyl)amino]-1-[3-(hydroxymethyl)-4-benzyloxyphenyl] ethanol
Salbutamol impurity J 2-[(1,1-dimethylethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethanone (salbutamone)
Salbutamol sulfate
Salbutamol sulfate for system suitability
Salicin
Salicylic acid
Salicylic acid impurity B 4-hydroxyisophthalic acid
Salmeterol xinafoate
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
50 mg
50 mg
300mg
160 mg
10 mg
unit
30 mg
50 mg
20 mg
0.015 mg
EPY0000714
EPY0000706
New EPY0001485
New EPY0001302
New EPY0001303
EPR1300000
80 mg
10 mg
1.0114 mg
200 mg
15 mg
2x1 mL
EPY0000594
EPY0000527
EPY0000742
EPY0000743
EPY0000786
EPR1500000
EPY0000220
EPR2000000
EPY0000494
EPY0000105
EPS0040000
EPS0050000
EPS0100000
EPY0000030
EPY0000071
unit
10 mg
10 mg
5 mg
40 mg
125 mg
5 mg
5x18 mg
10 mg
100 mg
30 mg
50 mg
50 mg
5 mg
5 mg
EPY0000031 5 mg
EPY0000034 5 mg
EPY0000032
EPY0001186
EPS0150000
EPY0001288
EPY0000669
EPS0200000
EPY0000405
EPY0000422
298
0.006 mg
0.00045 mg
50 mg
10 mg
50 mg
100 mg
10 mg
50 mg
Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000423
EPY0001052
EPY0001049
EPY0001056
New EPY0001483
EPY0000814
EPY0000815
EPS0360000
EPS0360090
EPS0400000
EPS0450000
EPS0460000
EPY0000828
EPY0000866
EPY0000867
EPY0001285
EPY0000371
EPY0001046
EPS0500000
EPS0600000
EPS0650000
EPY0001066
EPS0660000
EPY0000014
EPS0695000
EPY0000300
EPY0000039
EPS0700000
EPS0710000
EPS0750000
EPY0001300
EPS0760000
New EPY0001410
EPS0781000
EPS0780000
New EPY0001468
EPY0000620
EPY0000808
EPY0000809
EPS0785000
EPY0001104
EPY0000210
EPY0000268
EPS0800000
EPS0808000
EPS0808060
EPS0900000
EPS0930000
EPS0945000
EPS0947000
Salmeterol xinafoate for system suitability
Santonin
Saquinavir mesilate
Saquinavir for system suitability
Saw palmetto extract
Selamectin
Selamectin for system suitability
Selegiline hydrochloride
(RS)-Selegiline hydrochloride
Senna extract
Serine
Sertaconazole nitrate
Sertraline hydrochloride
Sertraline for peak identification
Sertraline for system suitability
Sertraline impurity E
Sestamibi labelling kit
Sevoflurane
Silicone elastomer
Silicone oil
Simvastatin
Simvastatin for peak identification
Sisomicin sulfate
Sodium alendronate
Sodium amidotrizoate
Sodium aminosalicylate dihydrate - Reference Spectrum
Sodium ascorbate
Sodium calcium edetate
Sodium cetostearyl sulfate
Sodium cromoglicate
Sodium cromoglicate for system suitability
Sodium cyclamate
Sodium fusidate
Sodium hyaluronate - Reference Spectrum
Sodium hyaluronate BRP
Sodium iodohippurate
Sodium laurilsulfate
Sodium phenylbutyrate
Sodium phenylbutyrate impurity C 4-cyclohexylbutanoic acid
Sodium picosulfate
Picosulfate for system suitability
Sodium polystyrene sulphonate - Reference Spectrum
Sodium propionate - Reference Spectrum
Sodium salicylate
Sodium stearyl fumarate
Sodium stearyl maleate
Sodium taurocholate BRP
Sodium valproate
Somatostatin
Somatropin
25 mg
20 mg
70 mg
0.3033 mg
8g
100 mg
5 mg
50 mg
25 mg
50 mg
50 mg
125 mg
200 mg
5.4 mg
6.18 mg
15 mg
22 mg
1 mL
2000 mg
1 mL
100 mg
10 mg
50 mg
150 mg
125 mg
unit
50 mg
100 mg
100 mg
10 mg
20 mg
100 mg
10 mg
unit
300 mg
15 mg
40 mg
5 mg
10 mg
100 mg
0.5 mg
unit
unit
100 mg
50 mg
10 mg
10000 mg
150 mg
2.45 mg
55 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 299
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000711
EPS0950000
EPY0000385
EPS1000000
EPY0000114
EPY0000115
EPY0001011
EPY0000597
EPY0000549
EPY0000655
EPY0001126
EPS1100000
EPY0000381
EPY0000332
EPS1200000
EPY0001295
EPY0000185
EPY0001050
EPY0001091
EPS1250000
EPS1250010
New EPY0001420
EPS1300000
EPY0000408
EPY0000421
EPS1340000
EPS1350000
EPY0000868
EPS1400000
EPS1500000
EPY0001324
EPY0001344
EPY0001342
Somatropin/desamidosomatropin resolution mixture
Sorbic acid
1,4-Sorbitan
Sorbitol
Sotalol hydrochloride
Sotalol impurity B N-[4-[[(1-methylethyl)amino]acetyl]phenyl]methanesulphonamide
Spanish sage oil for peak identification
Spectinomycin hydrochloride
Spectinomycin for system suitability
Spectinomycin sulphate tetrahydrate
Spike lavender oil
Spiramycin
Spirapril hydrochloride monohydrate
Spirapril for system suitability
Spironolactone
Spironolactone for system suitability
Squalane
St.John's wort standardised dry extract
Standardised artichoke leaf dry extract
Stanozolol
Stanozolol impurity A (5α,17β)-17-hydroxy-17-methylandrostan-3-one
Stanozolol impurity B
Starch BRP
Stavudine
Stavudine for system suitability
Stearic acid Plastic additive 19
Stearyl alcohol
Streptokinase for system suitability
Streptomycin sulphate
Succinylsulfathiazole
Sucralfate
Sucralose
Sucralose impurity B 1,6-dichloro-1,6-dideoxy-β-D-fructofuranosyl 6-chloro-6-deoxy-α-D-glucopyranoside (1‘,6,6‘-trichloro-1‘,6,6‘-trideoxysucrose)
Sucrose
Sufentanil - Reference Spectrum
Sufentanil citrate - Reference Spectrum
Sulbactam sodium
Sulbactam
Sulbactam for peak identification
Sulfacetamide sodium
Sulfadiazine
Sulfadiazine impurity A 2,6-dimethylaniline
Sulfadiazine for identification of impurity F
Sulfadimidine
Sulfadoxine
Sulfafurazole
Sulfaguanidine
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
33 mg
10 mg
50 mg
1200 mg
25 mg
20 mg
250 mg
100 mg
20 mg
10 mg
400 µl
200 mg
60 mg
15 mg
150 mg
2.055 mg
0.25 mL
500 mg
60 mg
50 mg
10 mg
10 mg
50000 mg
100 mg
10 mg
100 mg
250 mg
30 µl
100 mg
100 mg
10 mg
550 mg
0.5 mg
EPS1600000
EPS1608100
EPS1609000
EPY0000529
EPY0000528
EPY0000550
EPS1700000
EPS1800000
New EPY0001469
New EPY0001480
EPS1900000
EPS1950000
EPS1975000
EPS1975600
300
100 mg
unit
unit
10 mg
150 mg
20 mg
50 mg
100 mg
20 mg
15 mg
100 mg
50 mg
100 mg
60 mg
Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPS2000000
EPS2050000
EPS2100000
EPY0000412
EPY0000413
EPS2150000
EPS2151000
EPS2159100
EPS2155000
EPS2155010
EPS2158000
EPS2159000
EPY0001238
EPS2159010
EPS2159015
EPS2160000
EPS2180000
EPS2190000
EPS2191000
EPS2192000
EPY0000530
EPY0000531
EPY0000532
EPY0000022
EPY0000026
EPY0000027
EPS2200000
EPS2400000
EPS2400004
EPS2400006
EPS5000001
EPS5000002
New EPY0001417
EPT0010000
EPT0014000
EPT0015000
EPY0000650
EPY0000653
EPY0000651
EPY0000652
EPY0001102
EPY0001047
EPY0000648
Sulfamerazine
Sulfamethizole
Sulfamethoxazole
Sulfamethoxazole impurity A N-(4-(5-methyl)-isoxazol-3-ylsulphamoyl)phenylacetamide
Sulfamethoxazole impurity F 4-amino-N-(3-methylisoxazol-5-yl)benznesulphonamide
Sulfamethoxypyridazine
Sulfanilamide
Sulfapyridine
Sulfasalazine
Sulfasalazine derivative for resolution 2-hydroxy-5-[[4-[[(6-methylpyridin-2-yl)amino]-sulfonyl]phenyl]azo]benzoic acid
Sulfathiazole
Sulfinpyrazone
Sulfinpyrazone for system suitability
Sulfinpyrazone impurity A 1,2-diphenyl-4-(2-phenylsulphonylethyl)pyrazolidine-3,5-dione
Sulfinpyrazone impurity B 1,2-diphenyl-4-(2-phenylthioethyl)pyrazolidine-3,5-dione
Sulfisomidine
Sulindac
Sulpiride
Sulpiride impurity A [(2RS)-1-ethylpyrrolidin-2-yl]methanamine
Sulpiride impurity B methyl 2-methoxy-5-sulphamoylbenzoate
Sultamicillin
Sultamicillin tosilate
Sultamicillin for peak identification
Sumatriptan succinate
Sumatriptan impurity mixture
Sumatriptan for system suitability
Suxamethonium chloride
Suxibuzone
Suxibuzone impurity B (4-butyl-3,5-dioxo-1,2-diphenylpyrazolidin-4-yl)methyl ethyl butanedioate
Suxibuzone impurity C 4-butyl-4-(hydroxymethyl)-1,2-diphenyl-1,2-dihydro-4H-pyrazole-3,5-dione
Swine erysipelas bacteria, serotyp 1 (for vaccines-vet.use) BRP
Swine erysipelas bacteria, serotyp 2 (for vaccines-vet.use) BRP
Tadalafil
Talampicillin hydrochloride
Tamoxifen citrate
Tamoxifen citrate for performance test
Tamsulosin hydrochloride
Tamsulosin racemate
Tamsulosin impurity D 2-methoxy-5[(2R)-2-[[2-(2-methyoxyphenoxy)ethyl]amino]propyl]benzenesulfonamide
Tamsulosin impurity H (2R)-N-[2-(2-ethoxyphenoxy)ethyl]-1-(4-methoxyphenyl)propan-2-amine
Teicoplanin
Teicoplanin for identification
Telmisartan
100 mg
100 mg
50 mg
5 mg
5 mg
50 mg
100 mg
20 mg
2x250 mg
20 mg
100 mg
30 mg
0.5 mg
20 mg
20 mg
50 mg
50 mg
100 mg
20 mg
20 mg
10 mg
200 mg
10 mg
50 mg
3 mg
2 mg
1000 mg
50 mg
10 mg
10 mg
1 mg
1 mg
200 mg
50 mg
80 mg
30 mg
10 mg
10 mg
10 mg
10 mg
52 mg
40 mg
30 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 301
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000649
EPY0001003
EPT0040000
EPY0000344
Telmisartan for peak identification
Telmisartan for system suitability
Temazepam Controlled Substance
Temazepam impurity C (3RS)-7-chloro-1-methyl-2-oxo-5-phenyl-2,3-dihydro-1H-1,4-benzodiazepin-3-yl acetate Controlled Substance
Temazepam impurity D (3RS)-7-chloro-3-methoxy-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one Controlled Substance
Temazepam impurity F (5RS)-7-chloro-1-methyl-5-phenyl-4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione
Temazepam impurity G (5RS)-7-chloro-1,4-methyl-5-phenyl-4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione
Tenoxicam
Tenoxicam impurity mixture
Terazosin hydrochloride dihydrate
Terazosin for system suitability
Terazosin impurity A 2-chloro-6,7-dimethoxyquinazolin-4-amine
Terazosin impurity E 2,2`-(piperazine-1,4-diyl)bis(6,7-dimethoxyquinazolin-4-amine) Terazosin impurity L 1-(furan-2-ylcarbonyl)piperazine
Terazosin impurity N 1-[[(2RS)-tetrahydrofuran-2-yl]carbonyl]piperazine
Terbinafine hydrochloride
Terbinafine for system suitability
Terbutaline sulfate
Terbutaline impurity C 1-(3,5-dihydroxyphenyl)-2-[(1,1- dimethylethyl)amino]-ethanone
Terconazole
Terfenadine
Terfenadine impurity A 1-[4-(1,1-dimethylethyl)phenyl]-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl] butan-1-one (ketone)
Testosterone
Testosterone caproate
Testosterone decanoate
Testosterone decanoate for system suitability
Testosterone enantate
Testosterone enantate for peak identification
Testosterone enantate for system suitability
Testosterone enantate impurity H delta-5-testosterone-3,17-dienantate
Testosterone for impurity D identification
Testosterone for system suitability
Testosterone isocaproate
Testosterone isocaproate for system suitability
Testosterone propionate
Testosterone propionate for system suitability
Tetanus vaccine (adsorbed) BRP
Tetra-O-acetyl-mannose triflate
Tetracaine hydrochloride
Tetracaine for system suitability
Tetracosactide
10 mg
0.26 mg
50 mg
5 mg
EPY0000345 5 mg
EPY0000346
EPY0000347
EPT0040800
EPY0001114
EPY0000621
EPY0000666
EPY0000622
EPY0000665
EPY0000623
EPY0000624
EPY0000535
EPY0001143
EPT0050000
EPT0050015
EPT0060000
EPT0071000
EPT0080000
5 mg
5 mg
100 mg
0.0042 mg
40 mg
0.5 mg
10 mg
10 mg
10 mg
10 mg
10 mg
10 mg
100 mg
15 mg
250 mg
100 mg
20 mg
EPT0100000
EPT0210000
EPT0240000
EPY0000696
EPT0250000
EPY0001312
EPY0001317
EPY0001313
EPY0000342
EPY0000343
EPT0260000
EPY0000716
EPT0300000
New EPY0001409
EPT0400000
EPY0001087
EPT0500000
EPY0001002
EPT0550000
30 mg
50 mg
50 mg
0.4 mg
100 mg
10 mg
20 mg
10 mg
20 mg
20 mg
50 mg
5 mg
60 mg
5 mg
30 mg
60 mg
100 mg
2 mg
2x0.366mg
302 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPT0600000
EPY0001165
EPY0000015
EPY0000008
EPY0000460
EPY0000723
EPT0700000
EPT0800000
EPY0000294
EPY0000336
EPY0000372
EPY0000373
EPY0000467
EPY0000059
Tetracycline hydrochloride
Tetrandrine
Tetrazepam - Reference Spectrum
Tetrazepam impurity C 7-chloro-5-cyclohexyl-1-methyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one
Tetryzoline hydrochloride
Thebaine Controlled Substance
Theobromine
Theophylline
Theophylline - Reference Spectrum
Thiamazole
Thiamazol impurity A 2,2-dimethoxy-N-methylethanamine
Thiamazol impurity C 1-methyl-2-(methylsulphanyl)-1H-imidazole
Thiamine hydrochloride
Thiamine impurity E 3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-5-(2-hydroxyethyl) 4-methyl-4-thiazolidine-2-thione
Thiamine nitrate - Reference Spectrum
Thiamphenicol
Thioctic acid
Thioctic acid for system suitability
Thioctic acid containing impurity B
Thiomersal
Thiopental
Thiopental for system suitability
Thioridazine
Thioridazine hydrochloride
Thioridazine for system suitability
Thioxanthene
Thioxanthone
Threonine
Thymol
Tiabendazole
Tiamulin for peak identification
Tiamulin hydrogen fumarate
Tiamulin - Reference Spectrum
Tianeptine sodium - Reference Spectrum
Tianeptine for system suitability
Tianeptine impurity A ethyl 7-bromoheptanoate
Tiapride hydrochloride
Tiapride N-oxide
Tiaprofenic acid
Tiaprofenic acid impurity C (2RS)-2-(5-benzoylthiophen-3-yl)propanoic acid
Tibolone - Reference Spectrum
Tibolone for system suitability
Ticarcillin monosodium
Ticarcillin impurity A (2S,5R,6R)-3,3-dimethyl-7-oxo-6-[[(thiophen-3-yl)acetyl]-amino]-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylic acid (decarboxyticarcillin)
Ticlopidine hydrochloride
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
100 mg
20 mg
unit
20 mg
10 mg
10 mg
100 mg
100 mg
unit
125 mg
15 mg
20 mg
10 mg
10 mg
EPY0000060
EPT1100000
EPY0000546
EPY0000592
EPY0000545
EPY0000109
EPT1200000
New EPY0001478
EPY0000704
EPT1300000
EPY0000541
EPT1305100
EPT1305000
EPT1340000
EPT1350000
EPT1410000
EPY0000414
EPY0000333
EPY0000379
EPY0000151
EPY0000152
EPY0000153
EPT1405000
EPT1405050
EPT1410900
EPT1410910
EPY0000748
EPY0000668
EPY0000465
EPT1420010
unit
125 mg
110 mg
10 mg
30 mg
30 mg
500 mg
10 mg
10 mg
100 mg
0.21 mg
20 mg
10 mg
50 mg
50 mg
50 mg
10 mg
500 mg
unit
unit
30 mg
20 mg
60 mg
20 mg
50 mg
20 mg
unit
10 mg
250 mg
50 mg
EPT1423000
Edition 2012/2013
50 mg
303
Table of content
European Pharmacopoeia
Code Product Unit
EPT1423025
EPY0000325
EPY0001270
EPT1450000
EPY0000644
EPT1470000
EPY0000899
EPT1471000
EPT1490000
EPY0000292
EPY0000282
EPY0001188
EPY0001216
EPY0001179
EPY0001189
EPT1500000
EPY0001210
EPY0000383
EPY0000384
EPT1550000
EPT1600000
EPT1610000
EPT1700000
EPY0000154
EPT1707000
EPY0001123
EPY0000461
EPY0000462
EPY0001366
EPY0000155
EPY0000156
EPY0000157
EPY0000072
EPY0000065
EPY0000066
Ticlopidine impurity F 6-(2-chlorobenzyl)4,5,6,7-tetrahydrothieno [3,2-c]pyridine
Tilidine hydrochloride hemihydrate - Reference Spectrum
Timolol for system suitability
Timolol maleate
(R)-timolol
Tinidazole
Tinidazole impurity A 2-methyl-5-nitro-1H-imidazole
Tinidazole impurity B 1-(2-ethylsulphonylethyl)-2-methyl-4-nitroimidazole
Tinzaparin sodium
Tioconazole - Reference Spectrum
Tioconazole for system suitability
Tiotropium bromide monohydrate
Tiotropium impurity F dithiophen-2-ylmethanone
Tiotropium impurity mixture
Tiotropium for system suitability
Tobramycin
Tobramycin for identification
All-rac-alpha-tocopherol for peak identification
All-rac-alpha-tocopheryl acetate for peak identification
alpha-Tocopherol
alpha-Tocopheryl acetate
RRR-alpha-Tocopheryl hydrogen succinate
Tolbutamide
Tolfenamic acid
Tolnaftate
Tolnaftate for system suitability
Torasemide anhydrous
Torasemide for system suitability
Torasemide impurity E ethyl [[4-[(3-methylphenyl)amino]pyridin-3-yl]sulfonyl]carbamate
Tramadol hydrochloride
Tramadol impurity A (1RS,2SR)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol
Tramadol impurity E (2RS)-2-[(dimethylamino)methyl]cyclohexanone
Tramazoline hydrochloride monohydrate
Tramazoline impurity A N-(naphthalen-1-yl)-4,5-dihydro-1H-imidazol-2-amine
Tramazoline impurity B mixture of: 1-acetyl-2-[(5,6,7,8-tetrahydronaphthalen-1-yl)amino]-4,5-dihydro-1H-imidazole and N-(4,5-dihydro-1H-imidazol-2-yl)-N-(5,6,7,8-tetrahydronaphthalen-1-yl)acetamide
Trandolapril
Trandolapril impurity C (2S,3aR,7aS)-1-[(2S)-2-[[(1S)-3-cyclohexyl-1- (ethoxycarbonyl)propyl]amino]propanoyl]octahydro-1H-indole-2-carboxylic acid (hexahydrotrandolapril)
Trandolapril impurity D ethyl (2S)-2-[(3S,5aS,9aR,10aS)-3-methyl-1,4-dioxodecahydropyrazino[1,2-a]indol-2(1H)-yl]- 4-phenylbutanoate (trandolapril diketopiperazine)
Tranexamic acid
Trapidil
10 mg
unit
5.045 mg
100 mg
20 mg
100 mg
10 mg
20 mg
250 mg
unit
50 mg
10 mg
10 mg
0.08 mg
10 mg
51 mg
250 mg
15 mg
30 mg
500 mg
500 mg
150 mg
100 mg
100 mg
60 mg
10 mg
10 mg
5 mg
0.0006 mg
75 mg
15 mg
15 mg
20 mg
10 mg
10 mg
EPY0000501
EPY0000495
10 mg
10 mg
EPY0000496 10 mg
EPT1810000
EPT1820000
50 mg
50 mg
304 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPT1820002
EPT1820004
EPY0001172
EPT1850000
EPT1899000
EPG0400010
EPT1899990
EPT1900000
New EPY0001459
EPT1950000
EPY0000050
EPY0000837
EPY0000870
EPT1975000
EPY0000165
EPY0000166
EPY0001055
EPY0000279
EPY0000799
EPT1977990
EPT1977995
EPT1978000
EPY0000111
EPT1985000
EPT1986000
EPT2000000
EPT2005000
EPT2005010
EPY0000720
EPY0000108
EPY0000068
EPT2009000
EPY0001260
EPY0001319
EPY0000092
EPY0000093
EPT2100000
EPT2200000
EPY0000684
EPT2200010
EPT2450000
EPT2500000
EPY0000759
EPT2500100
EPT2501200
Trapidil impurity A 5-methyl-[1,2,4]triazolo[1,5-a]pyrimidin-7-ol
Trapidil impurity B 1,2,4-triazol-3-amine
Trehalose dihydrate
Tretinoin
3,4,6-Tri-O-acetyl-D-glucal - Reference Spectrum
Triacetin - Reference Spectrum
Triamcinolone
Triamcinolone acetonide
Triamcinolone acetonide for system suitability
Triamcinolone hexacetonide
Triamcinolone impurity C 9-fluoro-11ß-16alpha,17,21-tetrahydroxypregn-4-ene-3,20-dione
Triamterene
Triamterene impurity B 2,7-diamino-6-phenylpteridin-4-ol
Triazolam Controlled Substance
Tribenoside
Tribenoside impurity A 3,5,6-tri-O-benzyl-1,2-O-(1-methylethylidene)-α-D-glucofuranose
Tributyl acetylcitrate
Tri-n-butyl phosphate
Tributyl acetylcitrate for peak identification
Tricaprin
Tricaproin
Tricaprylin
Trichloroacetic acid - Reference Spectrum
Trichlorotrifluoroethane
Triethyl citrate - Reference Spectrum
Trifluoperazine hydrochloride
Triflusal
Triflusal impurity B 2-hydroxy-4-(trifluoromethyl)benzoic acid
Triglycerol diisostearate
Trihexyphenidyl hydrochloride
Trihexyphenidyl impurity A 1-phenyl-3-(piperidin-1-yl)propan-1-one
Trilaurin
Trimebutine for system suitability
Trimebutine maleate
Trimetazidine dihydrochloride - Reference Spectrum
Trimetazidine for system suitability
Trimethadione
Trimethoprim
Trimethoprim for system suitability
Trimethoprim impurity B (2,4-diaminopyrimidin-5-yl)(3,4,5- trimethoxyphenyl)methanone
Trimethyltetradecylammonium bromide
Trimipramine maleate
Trimipramine for peak identification
Trimyristin
Tristearin
20 mg
20 mg
250 mg
50 mg
unit
unit
150 mg
150 mg
10 mg
100 mg
10 mg
10 mg
0.5 mg
10 mg
150 mg
60 mg
1 mL
300 µL
25 mg
150 mg
40 mg
225 mg
unit
2.5 mL
unit
100 mg
50 mg
25 mg
200 mg
100 mg
20 mg
1250 mg
1.017 mg
10 mg
unit
50 mg
250 mg
50 mg
0.00075 mg
15 mg
200 mg
100 mg
0.51 mg
500 mg
100 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 305
Table of content
European Pharmacopoeia
Code Product Unit
EPT2545000
EPY0001184
EPY0001183
EPT2550000
EPT2580000
EPY0001316
EPY0001247
EPY0001248
EPY0000616
EPY0000618
EPT2580300
EPY0000429
EPY0000432
EPY0000431
EPY0000430
EPY0000497
EPT2600000
EPT2610000
EPT2800000
EPT2880000
EPT2880100
EPY0000498
EPT2880200
EPT2900000
EPT3000000
EPU0020000
EPU0020001
EPU0020008
Trolamine
Trolamine impurity A Ethanolamine
Trolamine impurity B Diethanolamine
Trometamol
Tropicamide
Tropicamide for peak identification
Tropicamide impurity C (2RS)-3-hydroxy-2-phenylpropanoic acid (tropic acid)
Tropicamide impurity D Phenylacetic acid Drug Precursor
Tropisetron hydrochloride
Tropisetron impurity B 1H-indole-3-carboxylic acid
Tropine
Trospium chloride
Trospium impurity A Hydroxydiphenylacetic acid (benzilic acid)
Trospium impurity B (1R,3r,5S)-8-azabicyclo[3.2.1]oct-3-yl hydroxydiphenylacetate
Trospium impurity C (1R,3r,5S)-3-hydroxyspiro[8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium]
Troxerutin
Trypsin BRP
Tryptophan
Tubocurarine chloride
Tylosin
Tylosin D
Tylosin phosphate for peak identification
Tylosin tartrate - Reference Spectrum
Tyrosine
Tyrothricin
Ubidecarenone
Ubidecarenone for system suitability
Ubidecarenone impurity D 5,6-dimethoxy-3-methyl-2-[(all-E)-3,7,11,15,19,23,27,31,35- nonamethylhexatriaconta-2,6,10,14,18,22,26,30,34-nonaenyl] benzene-1,4-dione
Uracil arabinoside
Urea
Ursodeoxycholic acid
Ursodeoxycholic acid for system suitability
Ursolic acid
Valaciclovir for system suitability
Valaciclovir hydrochloride (anhydrous)
Valaciclovir impurity D 2-[(2-amino-6-oxo-1,6dihydro-9H-purin-9-yl)methoxy]ethyl N-ethyl-L-valinate
Valaciclovir impurity E 2-[(2-amino-6-oxo-1,6dihydro-9H-purin-9-yl)methoxy]ethyl N-[(benzyloxy)carbonyl]-L-valinate
Valaciclovir impurity F para-toluenesulfonate 2-hydroxyethyl L-valinate
Valaciclovir impurity G N,N-dimethylpyridin-4-amine
Valerian standardised dry extract
Valine
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
2250 mg
250 mg
1 mL
100 mg
50 mg
10 mg
10 mg
10 mg
40 mg
10 mg
50 mg
10 mg
20 mg
20 mg
5 mg
30 mg
100 mg
100 mg
100 mg
150 mg
5 mg
10 mg
unit
50 mg
20 mg
50 mg
1 mg
5 mg
EPU0100000
EPU0600000
EPU0800000
EPY0001163
New EPY0001523
EPY0001225
EPY0000834
EPY0001096
EPY0001097
EPY0001098
EPY0001099
EPY0000583
EPV0030000
306
60 mg
100 mg
100 mg
1.26 mg
25 mg
10 mg
100 mg
10 mg
10 mg
12 mg
10 mg
400 mg
50 mg
Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000584
EPY0000533
EPY0000585
EPY0000586
Valnemulin hydrochloride
Valnemulin hydrogen tartrate
Valnemulin for peak identification
Valnemulin impurity E (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxodecahydro- 3a,9-propano-3aH-cyclopenta[8]annulen-8-yl 2-hydroxyacetate (pleuromulin)
Valproic acid
Valproic acid for system suitability
Valsartan
Valsartan for peak identification
Valsartan for system suitability
Vancomycin hydrochloride
Vanillin
Varicella vaccine (live)
Vecuronium bromide
Vecuronium for peak identification
Vedaprofen
Vedaprofen impurity mixture
Venlafaxine hydrochloride
Venlafaxine for system suitability
Verapamil hydrochloride
Verapamil impurity I (2RS)-2-(3,4-dimethoxyphenyl)-2-[2-[[2-(3,4)dimethoxyphenyl)- ethyl](methyl)amino]ethyl]3-methylbutanenitrile
Verapamil impurity M 5,5'-[[2-(3,4)dimethoxyphenyl)ethyl]imino]bis[2-(3,4-dimethoxyphenyl)- 2-(1-methylethyl)pentanenitrile
Verbenalin
VERO cells
Vigabatrin
Vigabatrin impurity A (5RS)-5-ethenylpyrrolidin-2-one
Vigabatrin impurity B (2E)-2-(2-aminoethyl)but-2-enoic acid
Vigabatrin impurity D 4-aminobutanoic acid
Vigabatrin impurity E 2-[(2RS)-2-aminobut-3-enyl]propanedioic acid
Viscosimeter calibration liquids
Vinblastine sulphate
Vinblastine sulfate - Reference Spectrum
Vincristine sulphate
Vincristine sulfate - Reference Spectrum
Vindesine sulphate
Vindesine sulfate - Reference Spectrum
Vinorelbine tartrate
Vinorelbine impurity B 4-O-deacetylvinorelbine
Vinpocetine
Vinpocetine impurity A (12RS,13aSR,13bSR)-13a-ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octahydro-1H- indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (ethyl vincaminate)
Vinpocetine impurity B (13aS,13bS)-13a-ethyl-2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1- ij][1,5]naphthyridine-12-carboxylate (apovincamine)
10 mg
120 mg
20 mg
10 mg
EPV0033000
New EPY0001422
EPY0001132
EPY0001131
EPY0001145
EPV0045000
EPV0050000
EPY0001198
EPY0000561
EPY0000625
EPY0001093
EPY0001118
EPY0000587
EPY0000588
EPV0100000
EPV0100018
100 mg
10 mg
10 mg
10 mg
0.202 mg
100 mg
100 mg
420 mg
10 mg
10 mg
5 mg
0.006 mg
50 mg
1 mg
100 mg
5 mg
EPV0100026 10 mg
EPY0000661
EPV0180000
New EPY0001400
New EPY0001401
New EPY0001402
New EPY0001404
New EPY0001403
EPV0200000
EPV0300000
EPV0305000
EPV0400000
EPV0405000
EPV0500000
EPV0500010
EPY0000463
EPY0000464
EPY0000589
EPY0000590
11 mg
2x1 mL
10 mg
25 mg
20 mg
50 mg
10 mg
250 mL
5 mg
unit
4.98 mg
unit
5.11 mg
unit
50 mg
7 mg
10 mg
10 mg
EPY0000591 10 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 307
Edition 2012/2013 Table of content
European Pharmacopoeia
Code Product Unit
EPY0000790 Vinpocetine impurity C ethyl(13aS,13bS)-13a-ethyl-9-methoxy-2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1- de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (methoxyvinpocetine)
Vinpocetine impurity D (12RS,13aRS,13bRS)-13a-ethyl-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1- de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (dihydrovinpocetine)
Vinyl acetate
Voriconazole
Voriconazole impurity B (2RS,3SR)-2-(2,4-difluorophenyl)-3-pyrimidin-4-yl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol
Voriconazole impurity D (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (epi-voriconazole)
Voriconazole impurity E [(1R,4S)-7,7-dimethyl-2-oxobicyclo[2.2.1]hept-1-yl]methanesulfonic acid ((+-)- camphorsulfonic acid)
Warfarin sodium
Warfarin sodium clathrate
Xylazine hydrochloride
Xylazine impurity C 2,6-dimethylphenyl isothiocyanate
Xylazine impurity E N-(2,6-dimethylphenyl)-S-methyldithiourea
Xylazine impurity mixture
Xylitol
Xylometazoline Hydrochloride
Xylometazoline impurity A N-(2-aminoethyl)-2-(4-1,1-dimethylethyl-2,6-dimethylphenyl)acetamide
Xylose
Yohimbine hydrochloride
Zidovudine
Zidovudine impurity A 1-[(2R,5S)-5-hydroxymethyl-2,5-dihydro-2-furyl]-5-methylpyrimidine-2,4(1H,3H)-dione
Zidovudine impurity B 1-(3-chloro-2,3-dideoxy-ß-D-ribofuranosyl)-5-methylpyrimidine-2,4(1H,3H)-dione
Zinc acexamate
Zinc acexamate impurity A 6-[[6-(acetylamino)hexanoyl]amino] hexanoic acid
Ziprasidone for system suitability 1
Ziprasidone for system suitability 2
Ziprasidone hydrochloride monohydrate
Zolpidem tartrate Controlled Substance
Zolpidem impurity A N,N'-dimethyl-2-[7-methyl-2-(4-methylphenyl)imidazol [1,2-a]pyridin-3-yl] acetamide
Zopiclone Controlled Substance
Zopiclone oxide
Zuclopenthixol decanoate - Reference Spectrum
Zuclopenthixol for system suitability
Zuclopenthixol impurity B 2-chloro-9H-thioxanthen-9-one
10 mg
EPY0000760 10 mg
EPY0000793
New EPY0001395
New EPY0001396
New EPY0001398
200 mg
120 mg
10 mg
10 mg
New EPY0001397 50 mg
EPW0100000
EPY0000778
EPX0075000
EPY0000158
EPY0000159
EPY0001224
EPX0080000
EPX0100000
EPX0101000
EPX0200000
EPY0000656
EPZ1900000
EPZ1902000
EPZ1904000
EPZ2000000
EPZ2000010
EPY0001272
EPY0001241
EPY0001286
EPZ2500000
EPZ2500010
10 mg
10 mg
125 mg
50 mg
15 mg
0.02 mg
500 mg
100 mg
10 mg
100 mg
20 mg
60 mg
10 mg
10 mg
50 mg
50 mg
10 mg
0.465 mg
100 mg
200 mg
10 mg
EPZ3000000
EPZ3001000
EPY0000062
EPY0000534
EPY0000083
60 mg
20 mg
unit
0.1 mg
10 mg
308 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.